Implantable urethral restriction device

Abstract

The present disclosure relates to techniques for restricting the urethra. More specifically, a constriction device is provided having one or more constriction elements configured to be expanded, thereby expanding in a first direction toward the urethra to constrict a first portion of the urethra to restrict fluid flow therethrough.

Description

[Technical Field]

[0001] The present invention relates to medical implants, and more particularly to medical implants for restricting the flow of urine in the urethra. [Background technology]

[0002] Because restricting a patient's urethra can be traumatic to the urethra, it would be advantageous to have a restriction device adapted to restrict the urethra in a less traumatic manner than prior art devices. Summary of the Invention

[0003] A support element for an implantable stricture device for constricting a patient's urethra is provided. The support element is configured to form at least a portion of a surrounding structure configured to surround and support at least one operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough. The support element includes at least one fluid conduit at least partially integrated into the support element. By integrating the fluid conduit within the support element, the fluid inlet to the operable hydraulic constriction element is protected and encapsulated by the support element, which reduces the space occupied by the operable hydraulic constriction element and reduces the amount of protrusion, thereby reducing the risk of damaging the urethra.

[0004] In one embodiment, the at least one fluid conduit is fully integrated into the support element.

[0005] In one embodiment, the support element comprises a connector for connecting the support element to another support element to at least partially form the perimeter structure. The support element may include a hinge portion for hingedly coupling the support element to another support element to at least partially form the perimeter structure. In one embodiment, the support element comprises a hinge portion at a first end of the support element and another connector portion at a second end for connecting to another portion of the support element or to another support element to at least partially form the perimeter structure.

[0006] In one embodiment, the support element comprises an inner surface configured to face the urethra when implanted. The inner surface may include a fixation surface for fixating at least one operable hydraulic constriction element, and the fixation surface may include at least one outlet from an at least partially integrated fluid conduit, allowing fluid to flow through the at least partially integrated fluid conduit to the operable hydraulic constriction element for constricting the urethra. In one embodiment, the inner surface constitutes a fixation surface for fixating at least two operable hydraulic constriction elements.

[0007] In one embodiment, the support element includes a second fluid conduit at least partially integrated into the support element, the first at least partially integrated fluid line configured to direct fluid to the first operable hydraulic constriction element, and the second at least partially integrated fluid line configured to direct fluid to the second operable hydraulic constriction element.

[0008] In one embodiment, the support element comprises at least one actuatable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough, the at least one actuatable hydraulic constriction element being in fluid communication with at least one fluid conduit at least partially integrated into the support element.

[0009] In one embodiment, the support element includes a second operable hydraulic constriction element, and at least one second operable hydraulic constriction element is in fluid communication with a second fluid conduit at least partially integrated into the support element.

[0010] In one embodiment, the first operable hydraulic constriction element has a larger volume than the second operable hydraulic constriction element, and the first operable hydraulic constriction element may have a volume that is at least 1.5 times larger than the volume of the second operable hydraulic constriction element, or may have a volume that is more than two times larger than the volume of the second operable hydraulic constriction element.

[0011] In one embodiment, the support element comprises an outer surface configured to face away from the urethra when implanted. The outer surface may include at least one inlet to at least one fluid conduit, the at least one inlet configured to be in fluid communication with a hydraulic pump for pumping fluid to an actuatable hydraulic constriction element to constrict the urethra.

[0012] In one embodiment, the support element, when implanted, has a length axially of the urethra, and the at least one operable hydraulic constriction element, when implanted, has a length axially of the urethra U. The length of the at least one operable hydraulic constriction element is greater than the length of the support element.

[0013] In one embodiment, the support element further comprises an electrode arrangement disposed between the support element and the urethra and configured to engage and electrically stimulate urethral muscle tissue to cause movement and improve long-term implant conditions of the implantable stricture device.

[0014] The support element in any of the embodiments herein, or the second, third, or fourth support element, can have at least one curvature that matches the curvature of the urethra.

[0015] The support element, or the second, third or fourth support element in any of the embodiments herein, can have a curvature with a radius in the range of 3 mm to 50 mm, or in the range of 5 mm to 30 mm.

[0016] The support element, or the second, third, or fourth support element in any of the embodiments herein, can have a first curvature having a first radius and a second curvature having a second radius, the first radius being smaller than the second radius.

[0017] The support element, or the second, third or fourth support element in any of the embodiments herein, may be substantially rigid and have a modulus of elasticity (E) in the range of 0.2 GPa to 1000 GPa or in the range of 1 GPa to 400 GPa, and the main portion of the support element may be made from a material having a modulus of elasticity (E) in the range of 0.2 GPa to 1000 GPa or in the range of 1 GPa to 400 GPa.

[0018] There is also provided a surrounding structure for an implantable stricture device for constricting a patient's urethra, the surrounding structure comprising at least one support element according to any embodiment herein configured to surround the urethra when implanted and including at least one fluid conduit at least partially integrated within the support element.

[0019] In one embodiment, the surrounding structure comprises a second support element, and the first and second support elements are configured to be connected and together form at least a portion of the surrounding structure. The first and second support elements can be configured to form the surrounding structure, thereby surrounding the urethra.

[0020] In one embodiment, the first support element and the second support element are hingedly connected to one another to form a surrounding structure, allowing a peripheral edge of the surrounding structure to open and allow the surrounding structure to be positioned around the urethra.

[0021] In one embodiment, the second support element comprises at least one operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough, and the at least one operable hydraulic constriction element may be in fluid communication with at least one fluid conduit at least partially integrated into the second support element.

[0022] In one embodiment, the second support element includes at least a second operable hydraulic constriction element, and the at least one second operable hydraulic constriction element is in fluid communication with a second fluid conduit at least partially integrated into the second support element.

[0023] In one embodiment, the second support element comprises at least one cushioning element configured to contact the urethra, which may be more resilient and / or elastic than the support element.

[0024] The surrounding structure may further include an electrode arrangement positioned between the surrounding structure and the urethra and configured to engage and electrically stimulate urethral muscle tissue to cause movement of the muscle tissue and improve long-term implant conditions of the implantable stricture device.

[0025] A surrounding structure for an implantable constriction device for constricting a patient's urethra is also provided. The surrounding structure can have a periphery that surrounds the urethra when implanted. The surrounding structure includes at least two support elements connected to each other to form at least a portion of the periphery of the surrounding structure. At least one of the support elements is configured to support at least one first operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough. Having the surrounding structure supporting the operable hydraulic constriction element ensures that the operable hydraulic constriction element has good support and counterforce for exerting pressure on the urethra. The surrounding structure can also function as a mount for the operable hydraulic constriction element(s) and as a fluid conduit for conducting hydraulic fluid to the operable hydraulic constriction element(s).

[0026] In one embodiment, the first and second support elements are configured to form a surrounding structure, thereby surrounding the urethra, and the support elements are hinged to one another to at least partially form the surrounding structure, the periphery of which is openable, thereby allowing the surrounding structure to be positioned around the urethra.

[0027] In one embodiment, the first support element comprises a first operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough, and in one embodiment, the first support element comprises at least one second operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough.

[0028] The first operable hydraulic constriction element may have a larger volume than the second operable hydraulic constriction element.

[0029] In one embodiment, the second support element includes a third operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough, and in one embodiment, the second support element includes a fourth operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough.

[0030] The third operable hydraulic constriction element may have a larger volume than the fourth operable hydraulic constriction element.

[0031] In one embodiment, the second support element may include at least one cushioning element configured to contact the urethra, and the cushioning element may be more resilient than at least one of the support elements.

[0032] In one embodiment, the surrounding structure has an axial length of the urethra when implanted, and the at least one first operable hydraulic constriction element has an axial length of the urethra when implanted, and the length of the at least one first operable hydraulic constriction element is longer than the length of the surrounding structure.

[0033] In one embodiment, the surrounding structure further comprises an electrode arrangement positioned between the surrounding structure and the urethra and configured to engage and electrically stimulate urethral muscle tissue to cause movement of the muscle tissue and improve long-term implant conditions of the implantable stricture device.

[0034] The surrounding structure in any of the embodiments herein can have at least one curvature C that matches the curvature of the urethra.

[0035] The surrounding structure in any of the embodiments herein can have a curvature with a radius in the range of 3 mm to 50 mm, or in the range of 5 mm to 30 mm.

[0036] The surrounding structure in any of the embodiments herein can have a first curvature having a first radius and a second curvature having a second radius, the first radius being smaller than the second radius.

[0037] The surrounding structure in any of the embodiments herein may be substantially rigid and have a modulus of elasticity (E) in the range of 0.2 GPa to 1000 GPa, or in the range of 1 GPa to 400 GPa, and the main portion of the support element may be made from a material having a modulus of elasticity (E) in the range of 0.2 GPa to 1000 GPa, or in the range of 1 GPa to 400 GPa.

[0038] Further provided is an implantable constriction device comprising the surrounding structure of any of the embodiments herein. The implantable constriction device further comprises at least one hydraulic pump and a control unit. The control unit is configured to control fluid flow from the hydraulic pump to expand the first hydraulically operable constriction element and contract the second hydraulically operable constriction element to constrict the urethra and restrict urine flow therethrough.

[0039] In one embodiment, the control unit is further configured to control the flow of fluid from the hydraulic pump to expand the third operable hydraulic constriction element and contract the fourth operable hydraulic constriction element to constrict the urethra and restrict the flow of urine therethrough.

[0040] In one embodiment, the control unit is further configured to control fluid flow from the hydraulic pump to contract the first operable hydraulic constriction element and expand the second operable hydraulic constriction element to release the urethral constriction and restore urethral flow.

[0041] In one embodiment, the control unit is further configured to control fluid flow from the hydraulic pump to contract the third operable hydraulic constriction element and expand the fourth operable hydraulic constriction element to release the urethral constriction and restore urethral flow.

[0042] In one embodiment, the implantable stricture device further comprises an electrode arrangement configured to be positioned between the implantable stricture device and the urethra and configured to engage and electrically stimulate urethral muscle tissue to exercise the muscle tissue to improve the long-term implant condition of the implantable stricture device.

[0043] In one embodiment, the implantable constriction device comprises first, second, and third urethral contact elements, the first urethral contact element comprising a first manipulable hydraulic constriction element configured to expand to constrict the urethra to restrict urine flow therethrough, the second urethral contact element comprising a second manipulable hydraulic constriction element configured to expand to assist in releasing the constriction of the urethra to restore urine flow therethrough, and the third urethral contact element comprising at least one cushion element configured to contact the urethra.

[0044] In one embodiment, the implantable stricture device comprises a surrounding structure having a periphery that surrounds the urethra when implanted, and at least one of the first, second, and third urethral contacting elements can be connected to the surrounding structure.

[0045] In one embodiment, the surrounding structure may be a surrounding structure in any embodiment herein and may be comprised of at least first and second support elements.

[0046] In one embodiment, the first urethral contact element is connected to the first support element and the second urethral contact element is connected to the second support element.

[0047] In one embodiment, the third urethral contact element is connected to the second support element.

[0048] In one embodiment, the first urethral contact element is connected to the first support element, the second urethral contact element is connected to the second support element, and the third urethral contact element is connected to the third support element.

[0049] In one embodiment, at least one of the first, second and third support elements has a curvature that matches the curvature of the urethra, and the curvature can have a radius in the range of 3 mm to 50 mm or in the range of 5 mm to 30 mm.

[0050] At least two support elements may be hinged to one another to form the perimeter structure.

[0051] The implantable constriction device may further include at least one hydraulic pump and a controller configured to control fluid flow from the hydraulic pump to expand the first operable hydraulic constriction element and contract the second operable hydraulic constriction element to constrict the urethra and restrict the flow of urine therethrough.

[0052] In one embodiment, the control device is further configured to control fluid flow from the hydraulic pump to contract the first operable hydraulic constriction element and expand the second operable hydraulic constriction element to release the urethral constriction and restore urethral flow.

[0053] In one embodiment, the first and second operable hydraulic constriction elements are connected to a shared hydraulic system such that hydraulic fluid is pumped from the first operable hydraulic constriction element to the second operable hydraulic constriction element to release the urethra and restore urethral flow, and from the second operable hydraulic constriction element to the first operable hydraulic constriction element to constrict the urethra and restrict urethral flow.

[0054] In one embodiment, the surrounding structure has a length in the axial direction of the urethra when implanted, and at least one of the first, second and third urethral contacting elements has a length in the axial direction of the urethra when implanted, and the length of at least one of the first, second and third urethral contacting elements is longer than the length of the surrounding structure.

[0055] The implantable stricture device (10) of any one of the preceding claims, further comprising an electrode arrangement positioned between the implantable stricture device (10) and the urethra (U) and configured to engage and electrically stimulate muscle tissue of the urethra (U) to cause movement of the muscle tissue and improve the long-term implant condition of the implantable stricture device (10).

[0056] A kit for a surrounding structure for an implantable stricture device for constricting a patient's urethra is also provided. The surrounding structure is configured to have a periphery that surrounds the urethra when implanted. The kit includes at least first, second, and third support elements, where the second support element is configured to be connected to the first support element to form at least a portion of the surrounding structure. The third support element is configured to be connected to the first support element to form at least a portion of the surrounding structure, and at least one of the second and third support elements is connected to the first support element to form at least a portion of the surrounding structure when the surrounding structure is implanted. Providing a kit of support elements allows the surrounding structure to be easily adapted to different urethras, allowing more complex portions of the implantable stricture device to be retained while simpler portions are replaced to adapt the implantable stricture device to a particular patient.

[0057] In one embodiment, the first support element is configured to support at least one first operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough.

[0058] In one embodiment, at least one of the first, second and third support elements has a curvature that matches the curvature of the urethra, and the curvature can have a radius in the range of 3 mm to 50 mm or in the range of 5 mm to 30 mm.

[0059] In one embodiment, the second support element has a second curvature that matches the curvature of the first urethra, and the third support element has a third curvature that matches the curvature of the second urethra, the second curvature being different from the third curvature. In this way, urethras with different curvatures can support assembly of the kit in different ways.

[0060] In one embodiment, the second curvature has a second radius, the third curvature has a third radius, and the second radius is greater than the third radius. The second radius may be 1.2 times or greater than the third radius.

[0061] In one embodiment, the second support element has a second length configured to extend along a portion of the periphery of the surrounding structure, and the third support element has a third length configured to extend along a portion of the periphery of the surrounding structure, the third length being longer than the second length.

[0062] The surrounding structure may have a modulus of elasticity (E) in the radial direction in the range of 0.2 GPa to 1000 GPa or in the range of 1 GPa to 400 GPa, and a major portion of at least one of the first, second and third support structures of the kit may be made from a material having a modulus of elasticity E in the range of 0.2 GPa to 1000 GPa or in the range of 1 GPa to 400 GPa.

[0063] In one embodiment, the first and second support elements may be configured to form a surrounding structure, thereby surrounding the urethra, or the first and third support elements may be configured to form a surrounding structure, thereby surrounding the urethra.

[0064] The second and third support elements can be configured to be hingedly connected to the first support element at least partially forming the surrounding structure, allowing a periphery of the surrounding structure to open and allow the surrounding structure to be positioned around the urethra.

[0065] The first support element may include a first operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough. In one embodiment, the first support element comprises at least one second operable hydraulic constriction element configured to constrict the urethra to restrict the flow of urine therethrough.

[0066] In one embodiment, the first operable hydraulic constriction element has a larger volume than the second operable hydraulic constriction element.

[0067] In one embodiment, at least one of the second and third support elements comprises a third operable hydraulic constriction element configured to constrict the urethra to restrict urine flow.

[0068] In one embodiment, at least one of the second and third support elements includes at least one cushioning element configured to contact the urethra, and the cushioning element may be more resilient and / or elastic than at least one of the support elements.

[0069] In one embodiment, the surrounding structure has a length in the axial direction of the urethra when implanted, and the at least one first operable hydraulic constriction element has a length in the axial direction of the urethra when implanted, and the length of the at least one first operable hydraulic constriction element is longer than the length of the surrounding structure.

[0070] In one embodiment, at least one of the first, second, and third support elements comprises an electrode arrangement positioned between the at least one of the first, second, and third support elements and the urethra and configured to engage and electrically stimulate urethral muscle tissue to cause movement and improve long-term implant conditions of the implantable stricture device.

[0071] In one embodiment, an implantable constriction device comprises a first operable hydraulic constriction element configured to be expanded to constrict the urethra to restrict the flow of urine therethrough, a second operable hydraulic constriction element configured to be expanded to constrict the urethra to restrict the flow of urine therethrough, and an interconnecting fluid conduit fluidly connecting the first operable hydraulic constriction element and the second operable hydraulic constriction element. The first operable hydraulic constriction element is configured to be positioned in a first portion of the urethra to constrict the first portion of the urethra and restrict urine flow therethrough, and the second operable hydraulic constriction element is configured to be positioned in a second portion of the urethra downstream from the first portion of the urethra to constrict the second portion of the urethra and restrict urine flow therethrough, and the communicating fluid conduit is configured to conduct fluid from the first operable hydraulic constriction element to the second operable hydraulic constriction element when pressure in the first operable hydraulic constriction element increases, causing the second operable hydraulic constriction element to further constrict the second portion of the urethra. In one embodiment, the lumen of the first operable hydraulic constriction element has a larger volume than the lumen of the second operable hydraulic constriction element.

[0072] In one embodiment, the lumen of the first operable hydraulic constriction element has a volume that is at least 1.5 times greater than the volume of the lumen of the second operable hydraulic constriction element.

[0073] The first interconnecting fluid line, in any of the embodiments herein, may include a first electrically operable valve to control fluid flow between the first and second operable hydraulic constriction elements, and the electrically operable valve may be a solenoid valve.

[0074] In any of the embodiments herein, the first interconnecting fluid line may be configured with a check valve such that fluid can flow in a direction from the first operable hydraulic constriction element to the second operable hydraulic constriction element, but not in a direction from the second operable hydraulic constriction element to the first operable hydraulic constriction element.

[0075] In one embodiment, the implantable constriction device further comprises a second interconnecting fluid conduit fluidly connecting the first manipulable hydraulic constriction element and the second manipulable hydraulic constriction element, wherein the cross-sectional area of ​​the lumen of the second interconnecting fluid conduit is less than 0.5 times the cross-sectional area of ​​the lumen of the first interconnecting fluid conduit.

[0076] The implantable constriction device of any one of the preceding claims further comprises a hydraulic pump, a reservoir for holding hydraulic fluid, and a first reservoir conduit fluidly connecting the reservoir to the first operable hydraulic constriction element, The hydraulic pump may be configured to pump fluid from the reservoir through the first reservoir conduit to the first operable hydraulic constriction element to constrict a first portion of the urethra to restrict the flow of urine therethrough.

[0077] The first reservoir line, in any of the embodiments herein, may include a second electrically operable valve to control fluid flow between the reservoir and the first operable hydraulic constriction element.

[0078] In one embodiment, the implantable constriction device further comprises a second reservoir conduit fluidly connecting the reservoir and the second operable hydraulic constriction element.

[0079] In any one of the embodiments herein, the second reservoir line may be configured with a check valve that allows fluid to flow from the reservoir to the second operable hydraulic constriction element, but prevents fluid from flowing from the second operable hydraulic constriction element to the reservoir.

[0080] The implantable constriction device may further include an injection port in fluid communication with the reservoir for injecting fluid into the reservoir when the reservoir is implanted.

[0081] In one embodiment, the injection port is configured to be placed subcutaneously, and the implantable constriction device may further include an injection port conduit fluidly connecting the injection port to the reservoir.

[0082] The implantable constriction device may further include at least one of a first pressure sensor configured to sense pressure within the first operable hydraulic constriction element and a second pressure sensor configured to sense pressure within the second operable hydraulic constriction element.

[0083] In one embodiment, the implantable stenosis device further comprises a controller configured to receive a pressure sensor signal from at least one of the first and second pressure sensors and to control at least one of the first electrically operable valve and the second operable valve and the hydraulic pump based on the received pressure sensor signal.

[0084] In one embodiment, the controller comprises a pressure threshold, and the controller is configured to open the first electrically operable valve when the received pressure sensor signal from the second pressure sensor exceeds the pressure threshold.

[0085] In one embodiment, the implantable constriction device further comprises a supportively operable hydraulic constriction element configured to be positioned along at least a portion of the first portion of the urethra and along at least a portion of the second portion of the urethra and configured to assist in constriction of the first and second portions of the urethra.

[0086] The supporting operable hydraulic constriction element may be connected to the first and second operable hydraulic constriction elements in any one of the embodiments herein. The supporting operable hydraulic constriction element may be less elastic than at least one of the first and second operable hydraulic constriction elements to make the combined operable hydraulic constriction element (consisting of the operable hydraulic constriction element and the supporting operable hydraulic constriction element) more rigid and less prone to deformation.

[0087] In one embodiment, each of the first, second, and supportably operable hydraulic constriction elements comprises a lumen surrounded by a resilient wall, and the resilient wall of the supportably operable hydraulic constriction element may be thicker than the wall of at least one of the first and second operable hydraulic constriction elements.

[0088] In one embodiment, the implantable constriction device further comprises a second hydraulic pump, a second reservoir for holding hydraulic fluid, and a support reservoir conduit fluidly connecting the second reservoir to the supportable hydraulic constriction element, the second hydraulic pump configured to pump fluid from the second reservoir through the support reservoir conduit to the supportable hydraulic constriction element to assist in constriction of the urethra.

[0089] The implantable constriction device may further include a third pressure sensor configured to sense pressure within the supportively steerable hydraulic constriction element.

[0090] The implantable constriction device may further include a second injection port in fluid communication with the second reservoir for injecting fluid into the second reservoir when the second reservoir is implanted. The second injection port may be configured for subcutaneous placement, and the implantable constriction device may further include a second injection port conduit fluidly connecting the second injection port to the second reservoir.

[0091] In one embodiment, the supporting maneuverable hydraulic constriction element, when implanted, has a urethral axial length, and the first and second maneuverable hydraulic constriction elements have a combined urethral axial length that is longer than the length of the supporting maneuverable hydraulic constriction element.

[0092] The surrounding structure, in any of the embodiments herein, may include an inner surface configured to face the urethra when implanted, and the supportable hydraulic constriction device may be secured to the inner surface of the surrounding structure such that the supportable hydraulic constriction device can use the surrounding structure as a support for constricting the urethra.

[0093] The implantable stricture device may further include at least one cushioning element configured to contact the urethra, the cushioning element being secured to an inner surface of the surrounding structure and being more resilient than the surrounding structure.

[0094] In any embodiment herein, the surrounding structure can be comprised of at least a first support element and a second support element configured to be connected to each other to form at least a portion of the periphery of the surrounding structure.

[0095] The supportable hydraulic constriction device may be secured to a first support element and the at least one cushioning element may be secured to a second support element.

[0096] An implantable stricture device for constricting a patient's urethra is also provided. The urethra is a tubular organ having a substantially circular cross-section and an elongated axial shape. The implantable stricture device can include a first operable hydraulic constriction element configured to be inflated, thereby expanding in a first direction toward the urethra and constricting a first portion of the urethra to restrict urine flow therethrough. The implantable stricture device can further include a supporting operable hydraulic constriction element configured to support the first operable hydraulic constriction element, thereby expanding in the first direction toward the urethra and constricting the first portion of the urethra to restrict urine flow therethrough. The combination of the first operable hydraulic constriction element and the supporting operable hydraulic constriction element can make the combined operable hydraulic constriction element more rigid, meaning more precise constriction of the urethra and a reduced risk of leakage when the implantable stricture device is closed.

[0097] The supporting operable hydraulic constriction element may in one embodiment be connected to the first operable hydraulic constriction element.

[0098] In one embodiment of the implantable constriction device, the supporting maneuverable hydraulic constriction element may be less elastic than the first maneuverable hydraulic constriction element.

[0099] In one embodiment, the first operable hydraulic constriction element may comprise a lumen surrounded by a resilient wall, and the support operable hydraulic constriction element may comprise a lumen surrounded by a resilient wall, and a portion of the resilient wall of the support operable hydraulic constriction element may be thicker than a portion of the resilient wall of the first operable hydraulic constriction element.

[0100] In one embodiment, the portion of the resilient wall of the supportable hydraulic constriction element may be 1.5 times thicker than the portion of the resilient wall of the first operable hydraulic constriction element, and in one embodiment, the portion of the resilient wall of the supportable hydraulic constriction element is 2 times thicker than the portion of the resilient wall of the first operable hydraulic constriction element.

[0101] In one embodiment, the first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, and the support operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, a portion of the resilient wall of the first operable hydraulic constriction element comprising a first material, and a portion of the resilient wall of the support operable hydraulic constriction element comprising a second material, which may have a higher modulus of elasticity than the first material.

[0102] In one embodiment, the modulus of elasticity of the second material is at least 1.5 times the modulus of elasticity of the first material, and in another embodiment, the modulus of elasticity of the second material is at least twice the modulus of elasticity of the first material.

[0103] In one embodiment, the implantable constriction device further comprises a first hydraulic pump, a second hydraulic pump, a first reservoir for holding hydraulic fluid, a second reservoir for holding hydraulic fluid, a first reservoir conduit fluidly connecting the first reservoir to the first operable hydraulic constriction element, and a support reservoir conduit fluidly connecting the second reservoir to the support operable hydraulic constriction element. The first hydraulic pump may be configured to pump fluid from the first reservoir through the first reservoir conduit to the first operable hydraulic constriction element to constrict the urethra, and the second hydraulic pump may be configured to pump fluid from the second reservoir through the support reservoir conduit to the support operable hydraulic constriction element to assist in constricting the urethra.

[0104] The implantable constriction device can further comprise a first pressure sensor configured to sense pressure within the first maneuverable hydraulic constriction element. The implantable constriction device can further comprise a second pressure sensor configured to sense pressure within the supporting maneuverable hydraulic constriction element.

[0105] The implantable constriction device, in any of the embodiments herein, may further include an implantable controller configured to control at least one of the first hydraulic pump based on input from the first pressure sensor and the second hydraulic pump based on input from the second pressure sensor.

[0106] The first reservoir conduit may include an electrically operable valve and the second reservoir conduit may include an electrically operable valve in any of the embodiments herein. The controller may be configured to control at least one of the electrically operable valves of the first reservoir conduit based on input from the first pressure sensor and to control the electrically operable valve of the second reservoir conduit based on input from the second pressure sensor.

[0107] At least one of the first reservoir conduit and the second reservoir conduit may further include a check valve.

[0108] In one embodiment, the implantable constriction device further comprises a first injection port in fluid communication with the first reservoir for injecting fluid into the first reservoir when the first reservoir is implanted.

[0109] The implantable constriction device may further include a second injection port in fluid communication with the second reservoir for injecting fluid into the second reservoir when the second reservoir is implanted. At least one of the first and second injection ports may be positioned subcutaneously, and the implantable constriction device further comprises first and / or second injection port conduits fluidly connecting the first injection port to the first reservoir and / or fluidly connecting the second injection port to the second reservoir.

[0110] In one embodiment, the supporting maneuverable hydraulic constriction element has an axial length of the urethra when implanted, and the first maneuverable hydraulic constriction element has an axial length of the urethra, and the length of the first maneuverable hydraulic constriction element may be longer than the length of the supporting maneuverable hydraulic constriction element.

[0111] In one embodiment, an implantable constriction device includes a first operable hydraulic constriction element configured to expand to exert pressure on the urethra in a first direction to constrict a first portion of the urethra to restrict urine flow; a second operable hydraulic constriction element configured to expand to exert pressure on the urethra in a second direction to constrict the first portion of the urethra to restrict urine flow; a first hydraulic system in fluid communication with the first operable hydraulic constriction element; and a second hydraulic system in fluid communication with the second operable hydraulic constriction element. The first and second operable hydraulic constriction elements are independently adjustable. In one embodiment, the second direction is substantially opposite to the first direction.

[0112] In one embodiment, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump. Each of the first and second hydraulic systems may include a reservoir for holding hydraulic fluid, and the first and second hydraulic systems may be connected to the reservoir for holding hydraulic fluid.

[0113] Each of the first and second hydraulic systems may include an injection port for infusing hydraulic fluid into the respective first and second hydraulic systems. The injection port may be configured for subcutaneous placement, and the implantable constriction device may further include an injection port conduit fluidly connecting the injection port to the first and second hydraulic systems.

[0114] In one embodiment, the first operable hydraulic constriction element lacks a fluid connection to the second operable hydraulic constriction element, and in such an embodiment, the two hydraulic systems can be completely separated, thereby providing increased redundancy.

[0115] The implantable constriction device may further comprise a first pressure sensor configured to sense pressure within the first operable hydraulic constriction element and / or a second pressure sensor configured to sense pressure within the second operable hydraulic constriction element.

[0116] The implantable constriction device may further include a controller configured to receive a pressure sensor signal from at least one of the first and second pressure sensors and to control at least one of the first hydraulic pump and the second hydraulic pump based on the received pressure sensor signal.

[0117] The implantable stricture device may include a peripheral structure having a periphery that surrounds the urethra when implanted, and the peripheral structure may be substantially rigid.

[0118] An implantable constriction device for constricting a patient's urethra is also provided. The implantable constriction device includes an actuatable hydraulic constriction element configured to expand to apply pressure to the urethra, a hydraulic reservoir for holding hydraulic fluid, and a hydraulic pump for pumping fluid from the hydraulic reservoir to the actuatable hydraulic constriction element. The implantable constriction device may further include a first fluid conduit forming a fluid connection between the hydraulic reservoir and the hydraulic pump, and a second fluid conduit forming a fluid connection between the hydraulic pump and the actuatable hydraulic constriction element. The implantable constriction device may further include an injection port for infusing and removing hydraulic fluid from the implantable constriction device when implanted, and a third fluid conduit forming a fluid connection between the injection port and at least one of the second fluid conduit and the actuatable hydraulic constriction element, allowing hydraulic fluid to be removed from the actuatable hydraulic constriction element via the injection port.

[0119] One advantage of having the injection port in direct fluid communication with the first and supporting operable hydraulic constriction element is that in the event of a pump failure in the electrically operable valve, the injection port can be used as a safety system through which hydraulic fluid can be removed from the first and supporting operable hydraulic constriction element. That is, in the event of a pump or valve failure, an injection needle can be inserted into the injection port and hydraulic fluid can be withdrawn from the first and supporting operable hydraulic constriction element, leaving the urethra unrestricted so that the patient can urinate even if the constriction device does not function.

[0120] In one embodiment, the implantable constriction device further comprises a support manipulable hydraulic constriction element configured to expand to support the first manipulable hydraulic constriction element in constricting the urethra to restrict urine flow.

[0121] The implantable constriction device may further comprise a second hydraulic reservoir for holding hydraulic fluid, a second hydraulic pump for pumping hydraulic fluid from the hydraulic reservoir to the supportable hydraulic constriction element, a fourth fluid line forming a fluid connection between the second hydraulic reservoir and the second hydraulic pump, and a fifth fluid line forming a fluid connection between the second hydraulic pump and the supportable hydraulic constriction element. The implantable constriction device may further comprise a second infusion port for infusing and removing hydraulic fluid from the implantable constriction device when implanted, and a sixth fluid line forming a fluid connection between the second infusion port and at least one of the second fluid line and the supportable hydraulic constriction element, allowing hydraulic fluid to be removed from the supportable hydraulic constriction element via the second infusion port.

[0122] A supporting operable hydraulic constriction element may be connected to the first operable hydraulic constriction element in any of the embodiments herein.

[0123] The supporting actuatable hydraulic constriction element may be less resilient than the first actuatable hydraulic constriction element.

[0124] In one embodiment of the implantable constriction device, the first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, and the support operable hydraulic constriction element comprises a lumen surrounded by a resilient wall. A portion of the resilient wall of the support operable hydraulic constriction element is thicker than the portion of the resilient wall of the first operable hydraulic constriction element. The portion of the resilient wall of the support operable hydraulic constriction element may be 1.5 times thicker than the portion of the resilient wall of the first operable hydraulic constriction element.

[0125] In one embodiment, the first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, and the support operable hydraulic constriction element comprises a lumen surrounded by a resilient wall. A portion of the resilient wall of the first operable hydraulic constriction element comprises a first material, and a portion of the resilient wall of the support operable hydraulic constriction element comprises a second material. The second material can have a higher elastic modulus than the first material. In one embodiment, the elastic modulus of the second material is at least 1.5 times higher than the elastic modulus of the first material.

[0126] In one embodiment, the implantable constriction device may further include a first pressure sensor configured to sense pressure within the first maneuverable hydraulic constriction element and / or a second pressure sensor configured to sense pressure within the supporting maneuverable hydraulic constriction element.

[0127] The implantable constriction device may further include an implantable controller configured to control at least one of the first hydraulic pumps based on input from the first pressure sensor and to control at least one of the second hydraulic pumps based on input from the second pressure sensor.

[0128] At least one of the first reservoir conduit and the second reservoir conduit may include an electrically operable valve, and the controller may be configured to control at least one of the electrically operable valves of the first reservoir conduit based on input from the first pressure sensor and to control the electrically operable valve of the second reservoir conduit based on input from the second pressure sensor.

[0129] The implantable constriction device may further include an implantable controller, which may be configured to provide a feedback signal to the patient when the pressure of at least one of the operable hydraulic constriction element and the supporting operable hydraulic constriction element exceeds a threshold value.

[0130] At least one of the first injection port and the second injection port may be configured to be placed subcutaneously.

[0131] In one embodiment, the supporting maneuverable hydraulic constriction element, when implanted, has an axial length of the urethra U, and the first maneuverable hydraulic constriction element has an axial length of the urethra U. The length of the first maneuverable hydraulic constriction element may be longer than the supporting maneuverable hydraulic constriction element.

[0132] The implantable stricture device may comprise a peripheral structure having a periphery that surrounds the urethra when implanted, and the peripheral structure may be substantially rigid.

[0133] In one embodiment, the implantable constriction device comprises an actuatable hydraulic constriction element configured to expand to apply pressure to the urethra and a hydraulic reservoir for holding hydraulic fluid, the implantable constriction device further comprises a hydraulic pump for pumping fluid from the hydraulic reservoir to the actuatable hydraulic constriction element, a first fluid conduit forming a fluid connection between the hydraulic reservoir and the hydraulic pump, and an electrode arrangement disposed between the implantable constriction device and the urethra, the electrode arrangement configured to engage and electrically stimulate urethral muscle tissue to exercise the muscle tissue to improve the long-term implant condition of the implantable constriction device.

[0134] The electrode arrangement may be disposed on the exterior surface of the steerable hydraulic constriction element.

[0135] In one embodiment, the electrode arrangement comprises a plurality of electrode elements, each configured to engage and electrically stimulate tissue of the urethra.

[0136] In one embodiment, the electrode arrangement comprises a coiled wire to increase the contact area between the electrode arrangement and the urethral tissue and enable the electrode arrangement to follow the contraction and relaxation of the urethral tissue.

[0137] The electrode arrangement may include exposed electrode portions configured to form a metal-tissue interface with the urethral tissue, thereby allowing faradaic charge transfer to be the predominant charge transfer mechanism across said interface.

[0138] In one embodiment, the electrode arrangement includes an electrode portion at least partially covered by a dielectric material configured to form a dielectric-tissue interface with the urethral tissue, thereby reducing the faradaic portion of the charge transfer mechanism across said interface.

[0139] The electrode arrangement may further include at least two electrode elements configured to be placed on opposite sides of the urethra.

[0140] The implantable stricture device may further comprise a stimulation controller configured to be operatively connected to the electrode arrangement to control electrical stimulation of the urethral tissue, The stimulation controller may be configured to control the electrical stimulation such that the urethral tissue is stimulated with a series of electrical pulses.

[0141] In one embodiment, the stimulation controller may be configured to control the electrical stimulation such that a pulse of a first polarity is followed by a pulse of a second, opposite polarity.

[0142] The stimulation control device may be further configured to generate a pulsed electrical stimulation signal having a pulse frequency of 0.01-150 Hz, a pulse duration of 0.01-100 ms, and a pulse amplitude of 1-15 mA.

[0143] In one embodiment, the electrical stimulation signal may consist of a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms, and a pulse amplitude of 3-10 mA.

[0144] In one embodiment, the electrical stimulation signal comprises a 0.01-2 second build-up period of gradually increasing amplitude, a 1-60 second stimulation period, and a 0.01-60 second rest period, and the electrical signal comprises a 1-50 Hz pulse frequency and a 0.1-10 ms pulse duration.

[0145] In one embodiment, the stimulation controller is configured to receive input from a wireless remote control. The implantable stricture device may further include an implantable sensor configured to sense action potentials generated by pacemaker cells in the urethral tissue, and the stimulation controller may be configured to control the electrical simulation based at least in part on the sensed action potentials.

[0146] In one embodiment, the stimulation controller can be configured to generate electrical pulses that amplify sensed action potentials.

[0147] In one embodiment, the implantable stricture device may include a surrounding structure having a periphery that surrounds the urethra when implanted, and the electrode arrangement may be connected to the surrounding structure.

[0148] The surrounding structure may be comprised of at least one cushioning element and at least one electrode element of the electrode arrangement may be arranged on a surface of the cushioning element.

[0149] In one embodiment, the implantable constriction device can include a first actuable hydraulic constriction element configured to expand to exert pressure on the urethra and a second actuable hydraulic constriction element configured to expand to exert pressure on the urethra. The implantable constriction device can further include a first hydraulic pump for pumping fluid through the actuable hydraulic constriction elements, a second hydraulic pump for pumping fluid through the actuable hydraulic constriction elements, and a motor M. The motor can be mechanically connected to the first and second hydraulic pumps to drive the first and second hydraulic pumps. The motor M can be, for example, an electric motor, such as a brushless implantable DC motor.

[0150] In one embodiment, the implantable constriction device further comprises a gear system disposed between the motor and the first and second hydraulic pumps, the gear system configured to reduce the speed and increase the force of motion generated by the motor to mechanically propel the first and second hydraulic pumps at lower speeds and greater forces.

[0151] In one embodiment, the motor is configured to generate rotational power and drive the first and second hydraulic pumps with rotational mechanical power. A rotational power output of the motor may be connected to a power input of a gear system, and the rotational power output of the gear system may be connected to the first and second hydraulic pumps.

[0152] The at least one first and second hydraulic pumps may comprise a gear pump, a peristaltic pump, a gerotor pump, or a pump including at least one compressible hydraulic reservoir.

[0153] In one embodiment, the first hydraulic pump comprises a first gerotor pump, the second hydraulic pump comprises a second gerotor pump, and the implantable constriction device further comprises a common rotatable shaft mechanically coupled to a motor. The inner rotor of the first gerotor pump may be mechanically connected to the common rotatable shaft, and the inner rotor of the second gerotor pump may be mechanically connected to the common rotatable shaft, such that the motor propels the first and second gerotor pumps. At least one of the first and second hydraulic pumps may be connected to an implantable reservoir.

[0154] In one embodiment, the implantable constriction device further comprises a first implantable reservoir and a second implantable reservoir, wherein the first hydraulic pump is connected to the first implantable reservoir and the second hydraulic pump is connected to the second implantable reservoir.

[0155] In one embodiment, the implantable constriction device further comprises an implantable reservoir, and the first and second hydraulic pumps may be connected to the implantable reservoirs for pumping hydraulic fluid from the first reservoir to the first operable hydraulic constriction element and from the second reservoir to the second operable hydraulic constriction element.

[0156] In one embodiment, the first operable hydraulic constriction element is configured to be inflated, thereby expanding in a first direction toward the urethra to constrict a first portion of the urethra and restrict the flow of urine therethrough; and the second operable hydraulic constriction element is a supporting operable hydraulic constriction element configured to support the first operable hydraulic constriction element when the second operable hydraulic constriction element is inflated, thereby expanding in the first direction d1 toward the urethra to constrict the first portion of the urethra and restrict the flow of urine therethrough, the supporting operable hydraulic constriction element may be connected to the first operable hydraulic constriction element, and the supporting operable hydraulic constriction element may be less elastic than the first operable hydraulic constriction element.

[0157] In one embodiment, the first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, and the support operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, wherein a portion of the resilient wall of the support operable hydraulic constriction element is thicker than a portion of the resilient wall of the first operable hydraulic constriction element.

[0158] In one embodiment, the implantable constriction device may further comprise a first pressure sensor configured to sense pressure within the first operable hydraulic constriction element and / or a second pressure sensor configured to sense pressure within the second operable hydraulic constriction element.

[0159] In one embodiment, the implantable constriction device may further comprise an implantable controller configured to control at least one of the first hydraulic pumps based on input from the first pressure sensor and to control at least one of the second hydraulic pumps based on input from the second pressure sensor.

[0160] In one embodiment, the implantable constriction device can further comprise a first and / or second implantable injection port in fluid communication with the first operable hydraulic constriction element.

[0161] In one embodiment, the second operable hydraulic constriction element has an axial length of the urethra when implanted, and the first operable hydraulic constriction element has an axial length of the urethra, the length of the first operable hydraulic constriction element being longer than the length of the second operable hydraulic constriction element.

[0162] In one embodiment, an implantable constriction device includes an actuatable hydraulic constriction element configured to expand to exert pressure on the urethra, a pressure sensor configured to sense pressure within the actuatable hydraulic constriction element, a hydraulic pump for pumping hydraulic fluid through the actuatable hydraulic constriction element, and a controller configured to receive a pressure sensor input from the pressure sensor and control the hydraulic pump based on the received pressure sensor input. The pressure sensor can include a diaphragm in fluid communication with the hydraulic fluid within the actuatable hydraulic constriction element and connected to a pressure-sensing element of the pressure sensor, the pressure-sensing element being isolated from the hydraulic fluid within the actuatable hydraulic constriction element by the diaphragm.

[0163] The pressure sensor can be a strain gauge pressure sensor, which is a piezo-resistive or piezoelectric strain gauge pressure sensor, or an optical strain gauge pressure sensor.

[0164] Alternatively, the pressure sensor may comprise a capacitive pressure sensor, which may be an electromagnetic pressure sensor.

[0165] In one embodiment, the diaphragm is in communication with a sealed lumen configured to hold a gaseous fluid, and the pressure sensing element is configured to sense a pressure of the gaseous fluid.

[0166] The implantable stenosis device may further include an electrically controllable valve connected to the controller, the controller being configured to control the electrically controllable valve based on the received pressure sensor input.

[0167] In one embodiment, the implantable constriction device may further include a reservoir for holding hydraulic fluid, the reservoir being in fluid communication with the actuatable hydraulic constriction element. The electrically controllable valve may be configured to open and close fluid communication between the reservoir and the actuatable hydraulic constriction element. The implantable constriction device may further include a second actuatable hydraulic constriction element and a second pressure sensor configured to sense pressure within the second actuatable hydraulic constriction element.

[0168] The implantable constriction device may further include a second hydraulic pump for pumping hydraulic fluid to the second operable hydraulic constriction element, and the controller may be configured to receive a pressure sensor input from the second pressure sensor and control the second hydraulic pump based on the received pressure sensor input.

[0169] In one embodiment, the implantable stenosis device further comprises a second electrically controllable valve connected to the controller, the controller configured to control the second electrically controllable valve based on the received pressure sensor input.

[0170] In one embodiment, the implantable constriction device further comprises a second reservoir for holding hydraulic fluid, the second reservoir being in fluid communication with the second operable hydraulic constriction element, and the second electrically controllable valve being configured to open and close fluid communication between the reservoir and the second operable hydraulic constriction element.

[0171] In one embodiment, the diaphragm is made from a medical grade silicone material.

[0172] In one embodiment, the diaphragm forms part of a wall of at least one of the actuatable hydraulic constriction element and the reservoir.

[0173] In one embodiment, the implantable constriction device includes an actuatable hydraulic constriction element configured to expand to apply pressure to the urethra and a hydraulic pump for pumping hydraulic fluid to the actuatable hydraulic constriction element. The hydraulic pump may include a compressible reservoir configured to hold hydraulic fluid for movement to the actuatable hydraulic constriction element. The implantable constriction device further includes a motor including a shaft. The motor may be configured to generate a radial force upon rotation of the shaft. The implantable constriction device further includes a transmission configured to transfer the radial force to a substantially axial force on the shaft for compressing the compressible reservoir. The implantable constriction device further includes at least one bearing for the shaft, the bearing configured to retain at least half of the axial force caused by compression of the reservoir to reduce axial load on at least one of the motor and the gear system.

[0174] The at least one bearing may comprise at least one of a ball bearing and a roller bearing, and the bearing may be disposed between the gear system and the compressible reservoir to reduce axial loads on the gear system caused by compression of the reservoir.

[0175] In one embodiment, the compressible reservoir comprises a first resilient wall, and the shaft may be directly or indirectly connected to the first resilient wall.

[0176] The compressible reservoir may be comprised of a first resilient wall and a second resilient wall, and the first resilient wall may be more resilient than the second resilient wall.

[0177] The implantable constriction device may further include a gear system connected to the motor and adapted to receive mechanical work via a shaft having a force and a speed, and to output mechanical work having a higher force and a lower speed.

[0178] A gear system may be disposed between the motor and the transmission.

[0179] The shaft may include a threaded portion, and the implantable constriction device may further include a compression member connected directly or indirectly to the first resilient wall portion. The compression member may include a corresponding threaded portion such that the threaded portions of the shaft and compression member together form a transmission. The compression member may be integral with the first resilient wall portion.

[0180] The implantable constriction device may further include a pressure sensor configured to sense pressure within the compressible reservoir, and the pressure sensor may be integrated into a wall portion of the compressible reservoir. The pressure sensor may comprise a strain gauge-based pressure sensor.

[0181] The first resilient wall may comprise a convex portion configured to be compressed and thus inverted to form a concave portion, and the second resilient wall may comprise a concave portion toward the lumen of the compressible reservoir. The first resilient wall may be configured to be compressed and inverted into the concave portion of the second resilient wall.

[0182] The compression member may include a protrusion configured to engage the first resilient wall portion to facilitate inversion of the protrusion of the first resilient wall portion. The implantable constriction device may further include a shaft seal configured to engage the shaft and provide a seal between the motor and at least one of the transmissions of the gear system.

[0183] The implantable constriction device may further include a resilient element configured to exert a resilient force on the shaft sealing such that the shaft sealing exerts a sealing force on the shaft. The shaft sealing may be constructed of a self-lubricating polymer material such as PTFE.

[0184] In one embodiment, the implantable, manipulable hydraulic constriction element comprises an abutment wall configured to engage the urethra to exert a force on the urethra, a retention wall configured to be connected to a retention structure for retaining the force exerted on the urethra such that the urethra U is constricted, and a connecting wall connecting the abutment wall to the retention wall. A first portion of the connecting wall is connected to the contact wall and a second portion of the connecting wall is connected to the retention wall. The first portion of the connecting wall is more resilient than the second portion of the connecting wall.

[0185] In one embodiment, the first portion of the connecting wall has an average wall thickness that is less than the average wall thickness of the second portion of the connecting wall.

[0186] The average thickness of the first portion of the connecting wall is less than 0.8 times the average thickness of the second portion of the connecting wall.

[0187] In one embodiment, the first portion of the connecting wall portion comprises a first portion and a second portion, the first portion of the first portion being connected to the abutment wall portion, the second portion of the connecting wall portion comprises a first portion and a second portion, a second sub-portion of the second portion being connected to the retention wall portion, and the first sub-portion of the first portion being more resilient than the second sub-portion of the first portion.

[0188] In one embodiment, the first sub-portion of the first portion has an average wall thickness that is less than the average wall thickness of the second sub-portion of the first portion.

[0189] The first sub-portion of the first portion may have an average wall thickness that is less than 0.9 times the average wall thickness of the second sub-portion of the first portion.

[0190] The first portion of the first section may be more resilient than the second portion of the first section.

[0191] The first sub-portion of the second portion may have an average wall thickness that is less than the average wall thickness of the second sub-portion of the second portion, and in one embodiment the first sub-portion of the second portion has an average wall thickness that is less than 0.9 times the average wall thickness of the second sub-portion of the second portion.

[0192] In one embodiment, a first portion of the connecting wall may be constructed from a first material and a second portion of the connecting wall may be constructed from a second material. The first material may have a lower modulus of elasticity than the first material. In one embodiment, the modulus of elasticity of the first material is less than 0.8 times the modulus of elasticity of the second material.

[0193] The retention structure in any of the embodiments herein may include a surrounding structure configured to surround the urethra. The surrounding structure may be comprised of first and second support elements configured to be coupled to each other to form the surrounding structure, and the first and second support elements may be hingedly coupled to each other.

[0194] The surrounding structure may include at least one cushioning element configured to contact the urethra, and the cushioning element may be more resilient than the surrounding structure.

[0195] In one embodiment, the implantable constriction device includes an actuatable hydraulic constriction element configured to expand to apply pressure to the urethra U, a hydraulic pump for pumping hydraulic fluid through the actuatable hydraulic constriction element, an implantable energy storage device, and a capacitor connected to the implantable energy storage device and connected to the hydraulic pump. The capacitor is configured to be charged by the implantable energy storage unit and to power the hydraulic pump. By charging the capacitor with the implantable energy storage unit, a hydraulic pump requiring a relatively large current can be operated using an implantable energy storage unit with a high energy density but a low maximum output current.

[0196] The implantable energy storage device may be a rechargeable battery, a solid state battery, and / or a thionyl chloride battery.

[0197] The implantable energy storage unit may be connected to the hydraulic pump and configured to power the hydraulic pump after starting the hydraulic pump using the capacitor.

[0198] The capacitor may be configured to store energy to provide a burst of energy to the hydraulic pump. The capacitor may be a start capacitor, a run capacitor, or a dual run capacitor.

[0199] In one embodiment, the implantable constriction device further comprises a second capacitor configured to be charged by the implantable energy storage unit and to power the hydraulic pump.

[0200] The capacitor may be, for example, a supercapacitor, which has a high capacitance relative to its size, which is important for keeping the implant small.

[0201] In one embodiment, the hydraulic pump may comprise an electric motor for actuating the hydraulic pump, and the capacitor may be further configured to provide power to at least one of a device for applying electrical stimulation to a tissue portion of the patient's body, a CPU for encrypting information, a transmitting unit and / or a receiving unit for communicating with an external unit, a measuring unit or sensor, a data collection unit, a solenoid, a piezoelectric element, and / or a memory metal unit.

[0202] In one embodiment, the capacitor is further configured to provide power to the valve.

[0203] The capacitor may also be configured to provide power to a control unit for controlling at least a portion of the medical implant.

[0204] The implantable constriction device may further comprise an external energy storage unit positioned outside the patient's body and configured to supply energy to the implantable energy storage unit, and an implantable energy receiver electrically connected to the implantable energy storage unit and configured to enable charging of the implantable energy storage unit by the external energy storage unit.

[0205] In one embodiment, the implantable constriction device further comprises a temperature sensor for sensing the temperature of the implantable energy storage unit and / or a temperature sensor for sensing the temperature of the capacitor.

[0206] In one embodiment, the implantable constriction device includes an actuatable hydraulic constriction element configured to expand to apply pressure to the urethra, a hydraulic pump for pumping hydraulic fluid to the actuatable hydraulic constriction element, and an internal control unit configured to control the hydraulic pump. The internal control unit can include a sensor adapted to detect magnetic fields and a processing unit having a sleep mode and an active mode. By having the sleep mode, the internal control unit consumes little energy when inactive.

[0207] The external control unit may be adapted to be placed outside the patient's body and may include a first coil adapted to generate a magnetic field detectable by the internal sensor. The internal control unit may be further configured to set the processing unit to an active mode in response to the detected magnetic field exceeding a predetermined value.

[0208] In one embodiment, the sensor is a Hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor, or a magnetoresistive sensor.

[0209] The frequency of the magnetic field generated by the coil can be 9 to 315 kHz.

[0210] In one embodiment, the frequency of the magnetic field generated by the coil is 125 kHz or less, preferably 58 kHz or less.

[0211] In one embodiment, the internal control unit comprises a receiving unit, and the internal control unit and the external control unit are configured to transmit and / or receive data via the receiving unit and the first coil via magnetic induction.

[0212] In one embodiment, the receiving unit comprises a sensitive magnetic field detector.

[0213] In one embodiment, the receiving unit comprises a second coil.

[0214] In one embodiment, the implantable constriction device further comprises an implantable energy storage unit electrically connected to the receiving unit, the implantable energy storage unit adapted to be charged by the external control unit via the receiving unit.

[0215] The implantable energy storage unit may be configured to be charged via magnetic induction between the first coil and the second coil.

[0216] The receiving unit may be configured to control the charging of the implantable energy storage unit by controlling the reception of power from the external control unit at the internal receiver.

[0217] The internal receiving unit may be configured to control charging of the implantable energy storage unit by controlling power transfer from the external control unit to the receiving unit.

[0218] In one embodiment, the implantable constriction device further comprises a sensation generator adapted to generate a sensation detectable by the patient's senses, the sensation generator being connected to an internal or external control unit and configured to generate a sensation when implanted in a patient upon demand.

[0219] In one embodiment, the sensation generator is configured to receive requests from an internal control unit or a medical implant, and the sensation generator may be configured to receive requests from an external device.

[0220] In one embodiment, the sensation generator may be configured to create a sensation consisting of multiple sensory components. The sensation generator may be configured to create the sensation or sensory component by at least one of vibrating the sensation generator, generating a sound to provide an optical signal, providing an optical signal, providing an electrical signal, and providing a thermal signal.

[0221] In one embodiment, the sensation generator may be adapted to be implanted in the patient, while in another embodiment, the sensation generator is configured to be worn in contact with the patient's skin. The sensation generator may also be configured to generate sensations without physical contact with the patient.

[0222] The external control unit may comprise a wireless remote control, which may comprise an external signal transmitter, and the internal receiver may be further configured to receive a signal transmitted by the external signal transmitter when the processing unit is in an active state and to control the operation of the device based on the signal.

[0223] The signal is selected from the group consisting of a sound signal, an ultrasonic signal, an electromagnetic wave signal, an infrared signal, a visible light signal, an ultraviolet signal, a laser signal, a microwave signal, a radio wave signal, an X-ray signal, and a gamma ray signal.

[0224] Further provided is a method of implanting an implantable stricture device according to any of the embodiments herein. The method includes the steps of placing at least two laparoscopic trocars into a patient suffering from urinary incontinence, inserting a dissection tool through the trocars to dissect a region of the urethra or urinary bladder around the abdomen, pelvis, or retroperitoneum, and placing an implantable stricture device in the dissected region to engage the urethra. The method may further include adjusting the implantable stricture device to normally restrict a urinary passageway of the urethra or urinary bladder, and adjusting the implantable stricture device to open the urinary passageway when the patient desires to void.

[0225] The method may further include implanting an energy source in the patient and providing a controller for controlling the energy source from outside the patient's body to provide energy for adjustment of the implantable stenosis device.

[0226] Further provided is a method of implanting an implantable stricture device according to any of the embodiments herein. The method includes making an incision in a patient's abdomen to access the subperitoneal space and thus the urethra, dissecting a portion of the urethra, inserting an implantable stricture device according to any of the embodiments herein into the patient, and positioning the implantable stricture device around the patient's urethra, which in some embodiments includes closing a locking or fixation device of the implantable stricture device around the urethra to position and fix the implantable stricture device in the patient's urethra, and optionally additionally fixating the implantable stricture device with, for example, sutures, staples, or a tissue growth-promoting structure such as a mesh configured to cover a portion of the implantable stricture device so that fibrotic tissue growth secures the implantable stricture device. In one embodiment, the method further includes inserting an implantable control device into the patient that is fixed to or securable to the implantable stricture device, and fixating the implantable control device to tissue or bone within the patient. In one embodiment, the method further includes inserting a manipulation device secured to or securable to the implantable stenosis device. The manipulation device may include at least one implantable hydraulic pump and / or at least one implantable valve, and secures the implantable manipulation device to tissue or bone within the patient's body. In one embodiment, the control device may be integrated into the manipulation device. The method may further include implanting and securing at least one injection port in fluid communication with the manipulation device. The step of securing the at least one injection port may include subcutaneously securing the injection port.The method may further include at least one of the steps of calibrating the fluid level in the implantable stricture device, calibrating the pressure exerted on the urethra by the implantable stricture device (which may include calibrating a control device to control a pump and / or valve accordingly), calibrating the time the implantable stricture device remains open after activation, calibrating the time the implantable stricture device remains open after activation before going to bed, calibrating the rate at which the implantable stricture device constricts the urethra, calibrating the pressure exerted on the urethra relative to the patient's blood pressure, calibrating the pressure acting on the urethra relative to the systolic blood pressure and / or diastolic blood pressure, which may include calibrating the pressure exerted on the urethra by the implantable stricture device by a pressure sensitive catheter, placing the implantable stricture device in a full open catheter mode, testing the feedback function by providing sensory feedback to the patient, placing the implantable stricture device in a post-operative mode to allow healing and / or growth of fibrotic tissue, and testing and / or calibrating electrical stimulation of tissue in the urethra.

[0227] There is also provided an implantable manipulation device for manipulating a hydraulic constriction element configured to exert a force on a patient's urethra, the implantable manipulation device comprising: a housing including first and second chambers separated from one another, the first chamber containing a first fluid and the second chamber containing a second fluid, the second fluid being a hydraulic fluid configured to transmit force to the hydraulic constriction element configured to exert a force on a body part of the patient.

[0228] According to one embodiment, the implantable manipulation device includes a motor housed within the first chamber, the motor configured to convert electrical energy into mechanical work. The implantable manipulation device can further include a hydraulic pump configured to pump hydraulic fluid from the manipulation device to the hydraulic constriction element configured to exert a force on the patient's urethra. The hydraulic pump can be a gear pump, a peristaltic pump, a pump including at least one compressible hydraulic reservoir, or a gerotor pump.

[0229] The implantable operating device may further include a transmission coupled between the motor and the hydraulic pump. The transmission may be configured to transfer high-speed cyclic force to low-speed strong force and / or to transfer rotational force to linear force. The transmission may be configured with a gear mechanism. A fluid chamber of the hydraulic pump forms part of the second chamber.

[0230] According to one embodiment, the implantable operating device may further comprise an implantable energy storage unit housed within the first chamber.

[0231] According to one embodiment, the implantable manipulation device further comprises a control device housed within the first chamber.

[0232] The walls of the first chamber may be elastic to allow expansion of the first chamber, and the walls may be comprised of an elastic membrane.

[0233] According to one embodiment, the first liquid is a non-conductive liquid.

[0234] According to one embodiment, the first liquid is a lubricating liquid.

[0235] According to one embodiment, the first liquid is an oily liquid such as mineral oil or silicone oil.

[0236] According to one embodiment, the second liquid is an isotone liquid.

[0237] According to one embodiment, the housing is made of a metallic material such as titanium.

[0238] According to one embodiment, the implantable manipulation device further comprises a conduit for electrical transport between the first and second chambers.

[0239] The wall separating the first and second chambers may be comprised of a portion made of an electrically insulating material, and the conduit may pass from the first chamber to the second chamber through the portion made of the electrically insulating material. The electrically insulating material may be comprised of a ceramic material.

[0240] There is also provided an implantable device for exerting a force on a body part of a patient, the implantable device comprising an implantable manipulation device as described in any one of the embodiments herein and a hydraulic constriction element configured to exert a force on the patient's urethra.

[0241]

[0006] Also provided is an implantable operating device for operating a hydraulic constriction element configured to exert a force on a patient's urethra. The implantable operating device includes a housing including first and second chambers separated from one another, and a motor housed in the first chamber, the motor configured to convert electrical energy into mechanical work. The implantable operating device further includes an actuator housed in the second chamber. The actuator is connected to the hydraulic constriction element configured to exert a force on the patient's urethra. The implantable operating device further includes a magnetic coupling for transmitting the mechanical work from the motor to the actuator through a barrier separating the first and second chambers.

[0242] According to one embodiment, the housing is made of a metallic material such as titanium.

[0243] In any embodiment, the actuator may be a hydraulic pump configured to transfer mechanical force to hydraulic force, and may comprise a gear pump, a peristaltic pump, a pump including at least one compressible hydraulic reservoir, or a gerotor pump.

[0244] The actuator may be a mechanical actuator configured to transfer a mechanical force from the magnetic coupling to the hydraulic constriction element to exert a force on the patient's urethra. The mechanical actuator may be configured to convert a rotational force into a linear force.

[0245] According to one embodiment, the magnetic coupling comprises a first coupling part made of a magnet or magnetic material configured in a first chamber, connected to a motor, and configured for rotational movement. The magnetic coupling can further comprise a second coupling part made of a magnet or magnetic material configured in a second chamber, connected to an actuator, and configured for propulsion by the rotational movement of the first coupling part.

[0246] The first connecting portion may be made of magnets or magnetic materials arranged radially around the periphery of the first connecting portion, and the second connecting portion may be made of magnets or magnetic materials arranged radially, such that the magnets or magnetic materials arranged radially on the first connecting portion magnetically connect to the magnets or magnetic materials arranged radially on the second connecting portion.

[0247] According to one embodiment, the first coupling part comprises a magnet or magnetic material axially arranged on a surface of the first coupling part, and the second coupling part comprises a magnet or magnetic material axially arranged on a surface of the first coupling part, such that the magnet or magnetic material axially arranged on the first coupling part magnetically connects to the magnet or magnetic material axially arranged on the second coupling part.

[0248] According to one embodiment, the implantable operating device according to any one of the preceding claims further comprises a transmission coupled between the motor and the magnetic coupling, the transmission being configured to transfer a high-speed cyclic force into a low-speed strong force, the transmission being configured as a gear system.

[0249] There is also provided a hydraulic constriction element for exerting a force on a body part of a patient, the hydraulic constriction element comprising an implantable manipulation device according to any one of the embodiments herein and a hydraulic constriction element configured to exert a force on the patient's urethra.

[0250] Further provided is an implantable hydraulic force transmission device. The implantable hydraulic force transmission device includes a first chamber configured to contain a first fluid, the first chamber including a first fluid connection for fluidly connecting the first chamber to an implantable manipulation device and at least one movable wall for varying the size of the first chamber. The implantable hydraulic force transmission device further includes a second chamber configured to contain a second fluid, the second chamber including a second fluid connection for fluidly connecting the second chamber to a hydraulic constriction element configured to exert a force on the patient's urethra and at least one movable wall for varying the size of the second chamber. The implantable hydraulic force transmission device can be configured to transmit hydraulic force from the implantable manipulation device to the hydraulic constriction element configured to exert a force on the patient's urethra without mixing the first and second fluids.

[0251] According to one embodiment, the implantable hydraulic force transmission device can form a common movable wall portion, wherein at least a portion of the movable wall of the first chamber forms the common movable wall portion and at least a portion of the movable wall of the second chamber forms the common movable wall portion.

[0252] At least one of the movable walls may comprise a piston, a first side of the piston facing the first chamber, and a second side of the piston facing the second chamber.

[0253] According to one embodiment, at least one of the movable walls consists of a flexible wall, which may be an elastic wall and / or a pleated wall.

[0254] According to one embodiment, at least one of the first and second chambers comprises a bellows.

[0255] According to one embodiment, the first chamber is configured to contain an oil-based fluid.

[0256] According to one embodiment, the second chamber is configured to contain an isotone fluid.

[0257] An implantable device for constricting a urethra to restrict urine flow therethrough is also provided. The implantable device can include an implantable operating device and a hydraulic constriction element configured to exert a force on a patient's body part. The implantable device may further include an implantable hydraulic force transmission device according to any one of the embodiments herein, a first fluid conduit configured to fluidly connect the implantable operating device to a first chamber of the implantable hydraulic force transmission device, and a second fluid conduit configured to fluidly connect the hydraulic constriction element configured to exert a force on a patient's body part to a second chamber of the implantable hydraulic force transmission device.

[0258] According to one embodiment, the operating device comprises a hydraulic pump for pumping hydraulic fluid from the operating device to the first chamber of the implantable hydraulic force transmission device. The implantable hydraulic according to any of the embodiments herein can comprise an implantable hydraulic for contracting the patient's urethra.

[0259] The implantable device according to any one of the embodiments may further comprise a first fluid configured to be transferred between the operating device and a first chamber of the implantable hydraulic force transmission device, and a second, different fluid configured to be transferred between the second chamber and the hydraulic constriction element configured to exert a force on the patient's urethra.

[0260] Further provided is an implantable control device for an implantable device for constricting a urethra to restrict the flow of urine therethrough. The control device is configured to control an operating device configured to operate at least one implantable element configured to exert a force on a patient's urethra. The implantable controller is further configured to receive a first input signal from an implantable sensor, the first input signal being at least one sensor input signal related to a physiological parameter of the patient. The implantable control device is further configured to receive a control signal from an implantable or external source, control the operating device to adjust the force exerted on the urethra in response to the first input signal, receive a second input signal from the implantable sensor related to a physiological parameter of the patient, and control the operating device to further adjust the force exerted on the urethra in response to the second input signal.

[0261] The physiological parameter, in any of the embodiments herein, may include a parameter related to oxygenation of a tissue portion of the patient, a parameter related to the patient's pulse rate, or a parameter related to the patient's blood pressure.

[0262] A method of calibrating an implantable urethra for constricting the urethra to restrict urine flow therethrough is also provided. The implantable constriction device includes at least one hydraulic constriction element configured to exert a force on a patient's body portion, an operating device for operating the hydraulic constriction element, and a controller for controlling the operating device. The method includes receiving, in the controller, a first input signal including at least one of a sensor input signal related to a patient's physiological parameter from an implantable sensor and a control signal from an implanted or external source. The method further includes controlling, by a controller, the operating device to adjust the force exerted on the urethra in response to the first input signal; receiving, in the controller, a second input signal related to the patient's physiological parameter from the implantable sensor; and controlling, by the controller, the operating device to further adjust the force exerted on the patient's body portion in response to the second input signal. Controlling the operating device to adjust the force exerted on the patient's urethra comprises adjusting the contraction of the urethra to adjust the restriction of urine flow.

[0263] According to one embodiment, receiving the first input signal at the controller may comprise a signal related to an input from the patient, an input from another unit within the controller, or an input from another controller, e.g., a time signal. Receiving the first input signal at the controller may comprise a signal from another sensor, which may be a motion sensor of an external device.

[0264] There is also provided an implantable control device for controlling an operating device for operating a hydraulic constriction element configured to exert a force on a urethral portion of a patient. The implantable controller comprises an electrical switch, which may be mechanically connected to the hydraulic constriction element configured to exert a force on a urethral portion of a patient and configured to be toggled as a result of the force exerted on the patient's body portion exceeding a threshold. The switch may be electrically connected to the operating device and configured to be toggled as a result of a current supplied to the operating device exceeding a threshold.

[0265] The control device, in any of the embodiments herein, may include a motor, and the switch may be electrically connected to the motor and configured to switch as a result of a current supplied to the motor exceeding a threshold. The switch may be configured to interrupt power to the control device and to generate a control signal to a processor of the implantable controller.

[0266] There is also provided an implantable constriction device for exerting a force on a body part of a patient, the implantable constriction device comprising an implantable manipulation device, a hydraulic constriction element configured to exert a force on the patient's urethra, and an implantable control device according to any one of the embodiments herein.

[0267] The operating device may include a motor, and the switch may be electrically connected to the motor and configured to switch as a result of a current supplied to the motor exceeding a threshold value.

[0268] The implantable device may further include a transmission coupled between the motor and the implantable element configured to exert a force on a body part of a patient, the transmission being configured to transfer a low force having a high speed to a high force having a low speed. The transmission may comprise a gear system.

[0269] According to one embodiment, the actuation device comprises a hydraulic pump for pumping hydraulic fluid from the actuation device to the implantable element configured to exert a force on a body part of a patient, the hydraulic pump may comprise a gear pump, a peristaltic pump, a pump including at least one compressible hydraulic reservoir, or a gerotor pump.

[0270] The implantable hydraulic constriction device may comprise an implantable hydraulic constriction device for constricting the urethra of a patient.

[0271] The embodiments, parts of embodiments, methods or parts of methods may be combined in any applicable manner.

[0272] Further provided is an implantable control device for controlling an operating device for operating an implantable constriction device to constrict the urethra to restrict the flow of urine therethrough, the implantable constriction device comprising a hydraulic constriction element configured to exert a force on the urethra. The implantable controller comprises an electrical switch comprising at least one of: a switch mechanically connected to the hydraulic constriction element to exert a force on a body part of a patient and configured to be switched as a result of the force exerted on the body part of the patient exceeding a threshold; a switch electrically connected to the operating device and configured to be switched as a result of a current supplied to the operating device exceeding a threshold; and a switch electrically connected to the operating device and configured to be switched as a result of a temperature exceeding a threshold.

[0273] According to one embodiment, the electrical switch is configured to be switched as a result of the pressure in the hydraulic constriction element exceeding a threshold value.

[0274] According to one embodiment, the operating device comprises a motor, the switch being electrically connected to the motor and configured to switch as a result of a current supplied to the motor exceeding a threshold value.

[0275] According to one embodiment, the switch is configured to cut power to the control device.

[0276] In one embodiment, the switch is configured to generate a control signal to a processor of the implantable controller.

[0277] There is also provided an implantable constriction device for exerting a force on a patient's urethra, the implantable manipulation device comprising a hydraulic constriction element configured to exert a force on the patient's urethra and an implantable control device according to any one of the embodiments herein.

[0278] In one embodiment, the operating device comprises a motor, and the switch is electrically connected to the motor and configured to switch as a result of a current supplied to the motor exceeding a threshold value.

[0279] The implantable device may further include a transmission coupled between the motor configured to exert a force on the patient's urethra and the hydraulic constriction element, the transmission configured to transfer the high-speed, constant force to a low-speed, high-intensity force. The transmission may comprise a gear system.

[0280] The operating device may include a hydraulic pump for pumping hydraulic fluid from the operating device to the hydraulic constriction element to apply force to the patient's urethra. The hydraulic pump may comprise a gear pump, a peristaltic pump, a pump including at least one compressible hydraulic reservoir, and / or a gerotor pump.

[0281] An implantable control device for an energized implant is also provided, the controller being configured to control an actuation device configured to actuate at least one hydraulic constriction element configured to exert a force on a body part of a patient, the implant controller being further configured to receive a first input signal related to pressure in the hydraulic constriction element configured to exert a force on the body part of the patient, receive a second input signal related to atmospheric pressure, and control the actuation device based on the received first and second input signals.

[0282] The implantable controller may be configured to receive a second input signal related to atmospheric pressure from a signal emitter configured to be positioned outside the patient's body, or may be configured to receive a second input signal related to atmospheric pressure from an implantable pressure sensor, and the implantable controller may be configured to control the force exerted on the patient's body based on the received first and second input signals.

[0283] According to one embodiment, the implantable controller may be configured to create an absolute pressure by subtracting atmospheric pressure from the pressure in the hydraulic constriction element, and the implantable controller may be configured to control the operating device based on the absolute pressure.

[0284] There is also provided an energized implant comprising an implantable control device according to any one of the embodiments described herein, at least one hydraulic constriction element configured to exert a force on the patient's urethra, and an operating device configured to operate the at least one hydraulic constriction element.

[0285] The energized implant can further comprise a pressure sensor configured to sense the pressure within the hydraulic constriction element and atmospheric pressure. In one embodiment, the energized implant further comprises a membrane, the pressure sensor configured to sense the pressure within the hydraulic constriction element on a first side of the membrane and to sense atmospheric pressure on a second side of the membrane. A portion of the wall in fluid communication with the at least one hydraulic constriction element configured to exert a force on a body part of a patient can comprise the membrane.

[0286] The sensor may be configured to derive the absolute pressure within the implantable element by comparing the pressure within the hydraulic constriction element to atmospheric pressure, or alternatively, the sensor may be configured to derive the pressure within the hydraulic constriction element by comparing the pressure within the hydraulic constriction element to a vacuum.

[0287] The pressure sensor comprises at least one of a strain gauge pressure sensor, a piezoresistive or piezoelectric pressure sensor, an optical pressure sensor, a capacitive pressure sensor, and an electromagnetic pressure sensor.

[0288] In one embodiment, the energized implant further comprises a first pressure sensor configured to sense a pressure within the hydraulic constriction element and a second pressure sensor configured to sense atmospheric pressure, The first pressure sensor may be connected to the at least one hydraulic constriction element implantable element configured to exert a force on a body part of a patient.

[0289] The second pressure sensor may be an implantable sensor located within or connected to the energized implant.

[0290] The hydraulic constriction element configured to apply a force to the patient's urethra can, in any of the embodiments herein, comprise a hydraulically actuable implantable element comprising a hydraulic pump.

[0291] Also provided is a method in an implantable control device for controlling an actuator of an implantable constriction device for constricting a urethra to restrict the flow of urine therethrough, the method including receiving a first input signal in the implantable control device, the first input signal related to pressure in a hydraulic constriction element configured to exert a force on a body part of a patient, receiving a second input signal in the implantable control device, the second input signal related to atmospheric pressure, and controlling, by the control device, the actuator based on the received first and second input signals.

[0292] According to one embodiment, the step of receiving the second input signal comprises receiving the second input signal from a signal transmitter located external to the patient's body.

[0293] According to one embodiment, the step of receiving a second input signal from a signal transmitter located outside the patient's body comprises receiving the second input signal in association with the patient using, operating or controlling the implantable constriction device.

[0294] According to one embodiment, the step of receiving the second input signal from a signal transmitter located outside the patient's body comprises receiving the second input signal wirelessly.

[0295] The step of receiving the second input signal may comprise receiving the second input signal from an implantable pressure sensor.

[0296] The step of controlling the operating device may comprise controlling a force exerted by the hydraulic constriction element on the patient's urethra based on the received first and second input signals.

[0297] The method may further include creating an absolute pressure in the control device by subtracting atmospheric pressure from the pressure within the implantable element, and controlling the operating device may include controlling the operating device based on the absolute pressure.

[0298] Further provided is a method in an implantable control device for controlling an actuation mechanism of an implantable constriction device to constrict the urethra and restrict the flow of urine therethrough, the method including releasing pressure in the implantable hydraulic constriction element so that the urethra is substantially free of pressure, measuring the pressure in the implantable hydraulic constriction element when the urethra is substantially free of pressure, and increasing the pressure in the implantable hydraulic constriction element to a predetermined level so that the urethra constricts.

[0299] According to one embodiment, the step of measuring the pressure within the implantable hydraulic constriction element when there is substantially no pressure applied to the urethra further comprises comparing the measured pressure to atmospheric pressure.

[0300] According to one embodiment, the step of comparing the measured pressure with atmospheric pressure comprises measuring the atmospheric pressure using a pressure sensor connected to a signal transmitter placed outside the patient's body.

[0301] According to one embodiment, the step of increasing the pressure in the implantable hydraulic constriction element to a predetermined level so as to constrict the urethra comprises constricting the urethra to a predetermined cross-sectional distance.

[0302] According to one embodiment, the method further includes measuring the pressure within the implantable hydraulic constriction element as the pressure within the implantable hydraulic constriction element increases.

[0303] According to one embodiment, the steps of measuring the pressure in the implantable hydraulic constriction element when there is substantially no pressure in the urethra and measuring the pressure in the implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element increases are performed using the same pressure sensor.

[0304] According to one embodiment, the method further comprises, in the control device, creating an absolute pressure by subtracting the pressure in the implantable hydraulic constriction element when substantially no pressure is acting on the urethra from the pressure in the implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element increases, and the step of controlling the operating device comprises controlling the operating device based on the absolute pressure.

[0305] There is also provided a controller for controlling pressure in an implantable constriction device to constrict the urethra, the controller comprising a pressure sensor for measuring pressure in the implantable hydraulic constriction element, and a computing unit configured to create an absolute pressure by subtracting the pressure in the implantable hydraulic constriction element when substantially no pressure is acting on the urethra from the pressure in the implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element increases.

[0306] According to one embodiment, the computing device is further configured to compare the measured pressure with atmospheric pressure.

[0307] According to one embodiment, the controller is further configured to receive a pressure signal from a pressure sensor located outside the patient's body and compare the measured pressure with the pressure received in the pressure signal.

[0308] According to one embodiment, the controller is configured to increase the pressure in the implantable hydraulic constriction element based on the measured pressure.

[0309] According to one embodiment, the control device is configured to increase pressure within the implantable hydraulic constriction element to a defined cross-sectional distance.

[0310] In either embodiment, the pressure applied to the reservoir and / or hydraulic constriction element can be controlled by controlling the actual pressure, by controlling the volume of fluid pumped, and / or by controlling the constricted urethral cross-sectional distance. That is, if the pressure is continuously calibrated, it can be established that a particular fluid level or distance leads to a particular pressure, making the device easier to control than controls using constant pressure measurements. In embodiments where the urethral fluid level or cross-sectional distance is used as the control value, the pressure can be used as a backup or safety system.

[0311] Medical devices designed to be implanted within a patient's body are typically powered by electrical power. These devices include electrical and mechanical stimulators, motors, pumps, and the like, which are designed to assist or stimulate various bodily functions. These implantable medical devices can be powered by either a battery that is also implanted, or by an external energy source that can provide any required amount of power, intermittently or continuously, without the need for repeated surgical procedures.

[0312] An implantable energy receiver or other implantable device necessary for the operation of an implantable medical device must somehow be placed within the patient's body in a safe and convenient manner. To minimize the distance between an external device, such as an energy transmitter, and the implanted device, the implanted device must often be placed close to the patient's skin. In practice, this means subcutaneous placement of the implanted device.

[0313] It is also often important that the implanted device remain in a relatively fixed position, for example, to ensure accurate energy delivery.

[0314] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a remote unit configured to be held in place by a tissue portion of a patient, the remote unit comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion. a connecting portion configured to be positioned through an opening in the tissue portion extending between the first portion and the second portion, the connecting portion having a third cross-sectional area in a third plane and a fourth cross-sectional area in a fourth plane, the connecting portion comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein the first, second, third, and fourth planes are parallel to one another and the third cross-sectional area is smaller than the first, second, and fourth cross-sectional areas, the first portion, the second portion, and the connecting portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes, and the first portion is removably connected to at least one of the connecting portion and the second portion.

[0315] In some embodiments, the connecting portion includes a flange defining a fourth cross-sectional area, the flange being configured to be prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0316] In some embodiments, the flanges project in directions parallel to the first, second, third and fourth planes and perpendicular to the central extension of the connecting portion.

[0317] In some embodiments, the flange comprises a third surface configured to engage a first tissue surface on the first side of the tissue portion.

[0318] In some embodiments, the connecting portion includes at least one protruding element defining a fourth cross-sectional area and configured to prevent the at least one protruding element from migrating through a hole in the tissue portion, thereby enabling the second portion and the connecting portion to be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0319] In some embodiments, the at least one projecting element projects in a direction parallel to the first, second, third and fourth planes and in a direction perpendicular to the central extension of the connecting portion.

[0320] In some embodiments, the at least one protruding element comprises a third surface configured to engage a first tissue surface on the first side of the tissue portion.

[0321] In some embodiments, the connecting portion comprises at least two protruding elements that define a fourth cross-sectional area.

[0322] In some embodiments, the at least two protruding elements are symmetrically arranged about the central axis of the connecting portion.

[0323] In some embodiments, the at least two protruding elements are asymmetrically positioned about the central axis of the connecting portion.

[0324] In some embodiments, at least one of the first, second, and third surfaces comprises at least one of ribs, barbs, hooks, a friction-enhancing surface treatment, and a friction-enhancing material to facilitate the remote unit being held in place by the tissue portion.

[0325] In some embodiments, the connecting portion comprises a hollow portion.

[0326] In some embodiments, the hollow portion provides a passageway between the first portion and the second portion.

[0327] In some embodiments, the first portion is removably connected to the connecting portion by at least one of a mechanical connection and a magnetic connection.

[0328] In some embodiments, the first portion is removably connected to the connecting portion by at least one of a thread and corresponding groove, a screw, a self-locking element, a twist-lock coupling, and a spring-loaded locking mechanism.

[0329] In some embodiments, the at least one protruding element has a height in a direction perpendicular to the fourth plane that is smaller than a height of the first portion in said direction.

[0330] In some embodiments, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than half of said height of said first portion in said direction.

[0331] In some embodiments, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than one-fourth of said height of said first portion in said direction.

[0332] In some embodiments, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than one tenth of said height of said first portion in said direction.

[0333] In some embodiments, at least one protruding element has a diameter in the fourth plane that is one of: smaller than the diameter of the first portion in the first plane; equal to the diameter of the first portion in the first plane; and larger than the diameter of the first portion in the first plane.

[0334] In some embodiments, at least one protruding element has a cross-sectional area in the fourth plane that is one of: smaller than the cross-sectional area of ​​the first portion in the first plane; equal to the cross-sectional area of ​​the first portion in the first plane; and larger than the cross-sectional area of ​​the first portion in the first plane.

[0335] In some embodiments, the at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than half the height of the connecting portion in said direction.

[0336] In some embodiments, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than one-quarter of said height of the connecting portion in said direction.

[0337] In some embodiments, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than one tenth of said height of the connecting portion in said direction.

[0338] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a remote unit configured to be held in place by a tissue portion of a patient, the remote unit comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane. a second surface having a cross-sectional area configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through a hole in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, the first portion and the second portion are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes, and the connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0339] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion in a first direction but not in a second direction perpendicular to the first direction.

[0340] In some embodiments, the connection interface between the connecting portion and the second portion is off-center relative to the second portion in a first direction and in a second direction perpendicular to the first direction.

[0341] In some embodiments, the first direction and the second direction are parallel to a second plane.

[0342] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0343] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0344] In some embodiments, the second portion is curved along its length.

[0345] In some embodiments, the second portion is curved in the first direction, and the second direction is perpendicular to the first direction.

[0346] In some embodiments, the first end and the second end each comprise an elliptical point.

[0347] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0348] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0349] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0350] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0351] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0352] In some embodiments, the second portion has a proximal region, an intermediate region, and a distal region.

[0353] In some embodiments, the proximal region extends from the first end to the interface between the connecting portion and the second portion, the intermediate region is defined by the connecting interface between the connecting portion and the second portion, and the distal region extends from the interface between the connecting portion and the second portion to the second end.

[0354] In some embodiments, the proximal region is shorter than the distal region with respect to the length of the second portion.

[0355] In some embodiments, the proximal region and the intermediate region together are shorter than the distal region with respect to the length of the second portion.

[0356] In some embodiments, the proximal region and the distal region comprise a second surface configured to engage a second surface of the second side of the tissue portion.

[0357] In some embodiments, the second portion is perpendicular to each other and has a length x and a width y along respective longitudinal and width directions that are substantially parallel to a second plane, and the connection interface between the connecting portion and the second portion is included within a region extending from x > 0 to x < x / 2 and / or from y > 0 to y < y / 2, where x and y and 0 are respective endpoints of the second portion along the longitudinal and width directions.

[0358] In some embodiments, the second portion is tapered from the first end towards the second end.

[0359] In some embodiments, the second portion is tapered from each of the first end and the second end towards the intermediate region of the second portion.

[0360] In some embodiments, the first portion has a maximum dimension in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, such as in the range of 15 to 25 mm.

[0361] In some embodiments, the first portion has a diameter in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0362] In some embodiments, the connecting portion has a maximum dimension in the third plane in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, for example in the range of 5 to 10 mm.

[0363] In some embodiments, the second portion has a maximum dimension in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, for example in the range of 35 to 60 mm.

[0364] In some embodiments, the first portion has one or more of a spherical shape, an ellipsoidal shape, a polyhedral shape, an elongated shape, and a flattened disk shape.

[0365] In some embodiments, the connecting portion has one of an oval cross-section, an elongated cross-section, and a circular cross-section in a plane parallel to the third plane.

[0366] In some embodiments, the distal region is configured to face downward in a standing patient.

[0367] In some embodiments, the first portion comprises a proximal region extending from the first end to an interface between the connecting portion and the first portion, an intermediate region defined by the connecting interface between the connecting portion and the first portion, and a distal region extending from the interface between the connecting portion and the first portion to a second end of the first portion.

[0368] In some embodiments, the first portion has a first height and the second portion has a second height, both heights being in a direction perpendicular to the first and second planes, and the first height being less than the second height.

[0369] In some embodiments, the first height is less than 2 / 3 of the second height, such as less than 1 / 2 of the second height, such as less than 1 / 3 of the second height.

[0370] In some embodiments, the second end of the second portion comprises a connection for connecting to an implant located caudally from the location of the remote unit within the patient.

[0371] In some embodiments, the first end of the second portion comprises a connection for connecting to an implant located cranially from the location of the remote unit within the patient.

[0372] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a remote unit configured to be held in place by a tissue portion of a patient, the remote unit comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a second plane. a third cross-sectional area in a plane configured to couple the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another, and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, such that the first portion and the second portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; the first cross-sectional area having a first cross-sectional distance and a second cross-sectional distance; The face distance and the second cross-sectional distance are perpendicular to each other, the first cross-sectional distance is longer than the second cross-sectional distance, the second cross-sectional area has a first cross-sectional distance and a second cross-sectional distance, the first cross-sectional distance and the second cross-sectional distance are perpendicular to each other, the first cross-sectional distance is longer than the second cross-sectional distance, and the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are rotationally displaced relative to each other by an angle greater than 45° to facilitate insertion of the second portion through the hole in the tissue portion.

[0373] In some embodiments, the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are rotationally displaced relative to one another by an angle greater than 60° to facilitate insertion of the second portion through a hole in the tissue portion.

[0374] In some embodiments, the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are substantially perpendicular to one another to facilitate insertion of the second portion through a hole in the tissue portion.

[0375] In some embodiments, the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are rotationally displaced relative to one another by an angle greater than 45° and less than 135°.

[0376] In some embodiments, the cross-sectional area of ​​the first portion is elongated.

[0377] In some embodiments, the cross-sectional area of ​​the second portion is elongated.

[0378] In some embodiments, the connecting portion is eccentrically connected to the second portion.

[0379] In some embodiments, a first cross-sectional distance of the second portion is divided into first, second and third equal length portions, and the connecting portion is connected to the second portion along the first length portion of the first cross-sectional distance.

[0380] In some embodiments, the first cross-sectional area of ​​the first portion is elongated.

[0381] In some embodiments, the second cross-sectional area of ​​the second portion is elongated.

[0382] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0383] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0384] In some embodiments, the second portion comprises a second wireless energy receiver.

[0385] In some embodiments, the first portion comprises a first energy storage unit.

[0386] In some embodiments, the second portion comprises a second energy storage unit.

[0387] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0388] In some embodiments, the solid state battery is a thionyl chloride battery.

[0389] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0390] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0391] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0392] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0393] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0394] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0395] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0396] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0397] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0398] In some embodiments, the remote unit further comprises a housing configured to enclose at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0399] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0400] In some embodiments, the remote unit further comprises a housing configured to enclose at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0401] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material. In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a remote unit configured to be held in place by a tissue portion of a patient, the remote unit comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned adjacent to the first portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area to prevent the first portion and the second portion from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane. The first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0402] In some embodiments, the remote unit further comprises at least one sensor for providing input to at least one of the first and second controllers.

[0403] In some embodiments, the sensor is a sensor configured to sense a physical parameter of the remote unit.

[0404] In some embodiments, the sensor is a sensor configured to sense at least one of a temperature of the remote unit or the body-engagement portion, a parameter related to power consumption of the remote unit or the body-engagement portion, a parameter related to the status of at least one of the first and second energy storage units, a parameter related to wireless transfer of energy from an energy source external to the patient's body, and fluid pressure.

[0405] In some embodiments, the sensor is a sensor configured to sense a physiological parameter of the patient.

[0406] In some embodiments, the sensor is a sensor configured to sense at least one of a parameter related to the patient's swallowing, local temperature, systemic temperature, blood saturation, blood oxygenation, blood pressure, a parameter related to an ischemic marker, and pH.

[0407] In some embodiments, the sensor configured to sense a parameter associated with the patient's swallowing comprises at least one of a motility sensor, an acoustic sensor, an optical sensor, and a strain sensor.

[0408] In some embodiments, the controller is configured to transmit information based on the sensor input to a device external to the patient's body.

[0409] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0410] In some embodiments, the second portion comprises at least one electric motor.

[0411] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion produced by the electric motor.

[0412] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0413] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0414] In some embodiments, the transmission comprises a gear system.

[0415] In some embodiments, the second portion comprises a magnetic coupling for transmitting mechanical work from the electric motor through one of a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing surrounding at least the second portion.

[0416] In some embodiments, the second part comprises at least one hydraulic pump.

[0417] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0418] In some embodiments, the remote unit further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0419] In some embodiments, at least one of the first and second portions comprises a sensation generator adapted to generate a sensation detectable by the patient's senses.

[0420] In some embodiments, the second portion comprises a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0421] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit force from the second portion to the implant engaging portion.

[0422] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted body engaging portion.

[0423] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0424] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0425] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0426] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of the patient.

[0427] In some embodiments, the walls of the first chamber are elastic to allow for expansion of the first chamber.

[0428] In some embodiments, the second portion comprises a first hydraulic system in fluid communication with a first hydraulically actuable implant element configured to exert a force on the patient's body part and a second hydraulic system in fluid communication with a second hydraulically actuable implant element configured to exert a force on the patient's body part, wherein the first and second hydraulically actuable implant elements are adjustable independently of one another.

[0429] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0430] In some embodiments, each of the first and second hydraulic systems includes a reservoir for holding hydraulic fluid.

[0431] In some embodiments, the implantable energized medical device further comprises a first pressure sensor configured to sense pressure in the first hydraulic system and a second pressure sensor configured to sense pressure in the second hydraulic system.

[0432] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0433] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0434] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a remote unit configured to be held in place by a tissue portion of a patient, the remote unit comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be positioned through an opening in the tissue portion extending between the first side and the second side, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, such that the first portion and the second portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; and at least one of the first portion and the second portion comprises at least one coil embedded in a ceramic material, the at least one coil configured for at least one of receiving wirelessly transmitted energy, wirelessly transmitting energy, receiving wireless communications, and transmitting wireless communications.

[0435] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0436] In some embodiments, the first portion comprises a first wireless communication receiver.

[0437] In some embodiments, the first portion comprises a coil embedded in a ceramic material, hereinafter referred to as the first coil.

[0438] In some embodiments, the first wireless energy receiver comprises a first coil.

[0439] In some embodiments, the first wireless communication receiver comprises a first coil.

[0440] In some embodiments, the first portion comprises a distal end and a proximal end relative to the connecting portion along a direction perpendicular to the first plane.

[0441] In some embodiments, the first coil is disposed at a distal end of the first portion.

[0442] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0443] In some embodiments, the first portion comprises a first wireless communication transmitter.

[0444] In some embodiments, the first portion comprises a coil embedded in a ceramic material, hereafter referred to as the second coil.

[0445] In some embodiments, the internal wireless energy transmitter comprises a second coil.

[0446] In some embodiments, the first wireless communication transmitter comprises the second coil.

[0447] In some embodiments, the second coil is disposed at the proximal end of the first portion.

[0448] In some embodiments, the first wireless energy receiver and the internal wireless energy transmitter are comprised of a single coil embedded in a ceramic material.

[0449] In some embodiments, the first wireless communication receiver and the first wireless communication transmitter comprise a single coil embedded in a ceramic material.

[0450] In some embodiments, the first wireless energy receiver, the internal wireless energy transmitter, the first wireless communications receiver, and the internal wireless communications transmitter are comprised of a single coil embedded in a ceramic material.

[0451] In some embodiments, the second portion comprises a second wireless energy receiver.

[0452] In some embodiments, the second portion includes a coil (hereinafter referred to as the third coil) embedded in a ceramic material, and the second wireless energy receiver includes the third coil.

[0453] In some embodiments, the second portion comprises a distal end and a proximal end relative to the connecting portion along a direction perpendicular to the first plane.

[0454] In some embodiments, the third coil is disposed at the proximal end of the second portion.

[0455] In some embodiments, the first portion comprises a first energy storage unit.

[0456] In some embodiments, the second portion comprises a second energy storage unit.

[0457] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0458] In some embodiments, the first energy storage unit is configured to store less energy than the second energy storage unit and is configured to charge faster than the second energy storage unit.

[0459] In some embodiments, the first energy storage unit has a lower energy density than the second energy storage unit.

[0460] In some embodiments, the remote unit further comprises a housing configured to enclose at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0461] In some embodiments, the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0462] In some embodiments, the remote unit further comprises a housing configured to enclose at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0463] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0464] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0465] In some embodiments, the connecting portion further includes a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second, and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0466] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0467] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0468] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0469] In accordance with one embodiment of the present concept, there is provided an implantable device for exerting a force on a body part of a patient, the implantable device comprising a remote unit and an implantable element configured to exert a force on the body part of the patient.

[0470] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable hydraulic constriction device.

[0471] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a method of implanting a remote unit, the method comprising: positioning a second portion of the remote unit between the peritoneum and a layer of abdominal wall musculature; and positioning a first portion of the remote unit between the patient's skin and the layer of abdominal wall musculature, the first and second portions being configured to be connected by a connecting portion extending through at least one layer of abdominal wall musculature; positioning a body-engaging portion of the remote unit relative to a tissue or organ of the patient to be affected by the remote unit; and positioning a transmission member configured to transmit at least one of energy and force from the second portion to the body-engaging portion at least partially between the peritoneum and the layer of abdominal wall musculature, such that at least one-third of the length of the transmission member is positioned outside the peritoneum.

[0472] In some embodiments, the transmission member is configured to transmit a mechanical force from the second portion to the body engaging portion.

[0473] In some embodiments, the transmission member is configured to transmit hydraulic force from the second portion to the body engaging portion.

[0474] In some embodiments, the transmission member is configured to transmit electrical energy force from the second portion to the body engagement portion.

[0475] In some embodiments, the transfer member is configured to transfer data between the second portion and the body engaging portion.

[0476] In some embodiments, the step of positioning the transfer member comprises at least partially positioning the transfer member between the peritoneum and a layer of abdominal wall muscle tissue such that at least half of the length of the transfer member is positioned outside the patient's peritoneum.

[0477] In some embodiments, the step of positioning the transfer member comprises at least partially positioning the transfer member between the peritoneum and a layer of abdominal wall muscle tissue such that at least two-thirds of the length of the transfer member is positioned outside the patient's peritoneum.

[0478] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member entirely outside of the patient's peritoneum.

[0479] In some embodiments, the step of positioning the transfer member includes positioning the transfer member to extend from the second portion outside the peritoneum to a region between the patient's rib cage and the peritoneum.

[0480] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member such that the transfer member extends from the second portion to a region between the patient's stomach and thoracic diaphragm.

[0481] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member such that the transfer member extends from the second portion to the patient's stomach.

[0482] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member such that the transfer member extends from the second portion to the patient's esophagus.

[0483] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the retroperitoneal space.

[0484] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the region of the kidney.

[0485] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the renal arteries.

[0486] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the subperitoneal space outside the peritoneum.

[0487] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member outside the peritoneum to extend from the second portion to the bladder.

[0488] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member outside the peritoneum to extend from the second portion to the urethra.

[0489] In some embodiments, the step of positioning the second portion of the remote unit between the peritoneum and the layer of abdominal wall musculature comprises positioning the second portion between the first and second layers of abdominal wall musculature.

[0490] In some embodiments, the step of disposing the second portion comprises disposing the second portion comprising an electric motor.

[0491] In some embodiments, the step of disposing the second portion comprises disposing the second portion comprising a hydraulic pump.

[0492] In some embodiments, the step of disposing the second portion includes disposing the second portion including an energy storage unit.

[0493] In some embodiments, the step of disposing the second portion includes disposing the second portion including a receiver for wirelessly receiving at least one of the energy and the communication.

[0494] In some embodiments, the step of disposing the first portion includes disposing the first portion including a transmitter for wirelessly transmitting at least one of energy and communications.

[0495] In some embodiments, the step of disposing the second portion comprises disposing the second portion comprising a controller responsible for controlling the powered medical device.

[0496] In some embodiments, the second portion is elongate and has a length axis extending substantially in an elongate direction of the second portion, and the step of positioning the second portion includes positioning the second portion such that the length axis is substantially parallel to the cranio-coccygeal axis of the patient.

[0497] In some embodiments, the second portion is elongate and has a length axis extending substantially in an elongate direction of the second portion, and the step of positioning the second portion includes positioning the second portion such that the length axis is substantially perpendicular to the patient's cranio-coccygeal axis.

[0498] In some embodiments, the second portion is elongated and has a length axis extending substantially in the elongated direction of the second portion, and the step of positioning the second portion includes piercing a layer of muscle tissue of the stomach wall in the direction of the length axis of the second portion and pivoting or angling the second portion after the piercing is achieved.

[0499] In some embodiments, the step of placing a first portion of the remote unit between the patient's skin and the layer of musculature of the abdominal wall comprises placing the first portion in subcutaneous tissue.

[0500] In some embodiments, the step of positioning the first portion of the remote unit between the patient's skin and the layer of abdominal wall musculature comprises positioning the first portion between the first layer and the second layer of abdominal wall musculature.

[0501] In some embodiments, the step of disposing the first portion includes disposing the first portion including an energy storage unit.

[0502] In some embodiments, the step of disposing the first portion includes disposing the first portion including a receiver for wirelessly receiving at least one of the energy and the communication.

[0503] In some embodiments, the step of disposing the first portion includes disposing the first portion including a transmitter for wirelessly transmitting at least one of energy and communications.

[0504] In some embodiments, the step of disposing the first portion comprises disposing the first portion to comprise a controller responsible for controlling the powered medical device.

[0505] In some embodiments, the first portion is elongate and has a length axis extending substantially in an elongate direction of the first portion, and the step of positioning the first portion includes positioning the first portion such that the length axis is substantially parallel to the cranio-coccygeal axis of the patient.

[0506] In some embodiments, the first portion is elongate and has a length axis extending substantially in an elongate direction of the first portion, and the step of positioning the first portion includes positioning the first portion such that the length axis is substantially perpendicular to a cranio-cranial axis of the patient.

[0507] In some embodiments, the first portion is elongated and has a first portion major axis extending substantially in the direction of elongation of the first portion, the second portion is elongated and has a second portion major axis extending substantially in the direction of elongation of the second portion, and the step of positioning the first portion and the second portion includes positioning the first portion and the second portion such that the first portion major axis and the second portion major axis are positioned at an angle of greater than 30° relative to each other.

[0508] In some embodiments, the step of positioning the first portion and the second portion includes positioning the first portion and the second portion such that the first portion major axis and the second portion major axis are positioned at an angle of greater than 45° relative to one another.

[0509] In some embodiments, the method further comprises placing a connecting portion through at least one layer of abdominal wall musculature.

[0510] In some embodiments, the first moiety, second moiety and linking moiety are part of a single unit.

[0511] In some embodiments, the method further comprises linking the first portion to the linking portion in situ.

[0512] In some embodiments, the method further comprises connecting the second portion to the connecting portion in situ.

[0513] In some embodiments, the method further includes connecting a transfer member to the first portion.

[0514] In some embodiments, the method further comprises coupling a transfer member to the body engaging portion.

[0515] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a kit for assembling a remote unit configured to be held in place by a tissue portion of a patient, the kit including: a group of one or more first portions, a group of one or more second portions, and a group of one or more connecting portions, at least one of said groups being composed of at least two different types of said portions; the remote unit being a modular device that, when assembled, is comprised of selecting one first portion, one second portion, and one connecting portion from said group, wherein the first portion is configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane, and the first portion is configured to be positioned on the first side of the tissue portion. the first surface configured to face the first tissue surface of the tissue portion; the second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion; the connecting portion configured to be disposed through an opening in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, so as to prevent movement of the first and second portions through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0516] In general, any of the remote unit embodiments disclosed herein may form part of such a kit, and features of such embodiments may be combined to form part of such a kit.

[0517] In some embodiments, the group of one or more first portions comprises a first portion including a first energy storage unit.

[0518] In some embodiments, the group of one or more first portions comprises a first portion including a first wireless energy receiving unit for receiving energy wirelessly transmitted by an external wireless energy transmitter.

[0519] In some embodiments, the first energy storage unit is connected to a first wireless energy receiver, and the first wireless energy receiver is configured to receive energy wirelessly transmitted by an external wireless energy transmitter and store the received energy in the first energy storage unit.

[0520] In some embodiments, the first wireless energy receiver is configured to be physically connected to a second energy storage unit of the second portion.

[0521] In some embodiments, the group of one or more first portions comprises a first portion that includes an internal wireless energy transmitter.

[0522] In some embodiments, the group of one or more second portions comprises a second portion including a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter.

[0523] In some embodiments, the internal wireless energy transmitter is configured to wirelessly transmit energy to a second wireless energy receiver.

[0524] In some embodiments, the group of one or more second portions comprises a second portion including a second energy storage unit connected to a second wireless energy receiver.

[0525] In some embodiments, the second wireless energy receiver is configured to receive energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0526] In some embodiments, the group of one or more first portions consists of a first portion integrally formed with a connecting portion.

[0527] In some embodiments, the group of one or more second portions comprises a second portion integrally formed with a connecting portion.

[0528] In some embodiments, one of the groups of one or more first portions, second portions, or connecting portions consists of the first portion, second portion, and connecting portion formed as one integral unit.

[0529] In some embodiments, the group of one or more first portions includes a first portion having a first height along a direction perpendicular to the first plane and a first portion having a second height along the direction perpendicular to the first plane, the second height being greater than the first height.

[0530] In some embodiments, the group of one or more first portions includes a first portion having a first width and / or length along a direction parallel to the first plane and a first portion having a second width and / or length along the direction parallel to the first plane, the second width and / or length being greater than the first width and / or length.

[0531] In some embodiments, the group of one or more second portions includes a second portion having a first height along a direction perpendicular to the second plane and a second portion having a second height along the direction perpendicular to the second plane, the second height being greater than the first height.

[0532] In some embodiments, the group of one or more second portions includes a second portion having a first width and / or length along a direction parallel to the second plane and a second portion having a second width and / or length along the direction parallel to the second plane, the second width and / or length being greater than the first width and / or length.

[0533] In some embodiments, the group of one or more linking portions comprises linking portions having a first height along a direction perpendicular to the third plane and linking portions having a second height along the direction perpendicular to the third plane, the second height being greater than the first height.

[0534] In some embodiments, the group of one or more linking portions comprises linking portions having a first width and / or length along a direction parallel to the third plane and linking portions having a second width and / or length along said direction parallel to the third plane, the second width and / or length being greater than the first width and / or length.

[0535] In some embodiments, the group of one or more first portions comprises a first portion that includes an injection port for injecting a fluid into the first portion.

[0536] In some embodiments, the group of one or more connection portions comprises a connection portion that includes a hydraulic fluid conduit for hydraulically connecting a first portion to a second portion.

[0537] In some embodiments, the group of one or more first portions comprises a first portion including a first controller including at least one processing unit.

[0538] In some embodiments, the group of one or more second portions comprises a second portion including a second controller including at least one processing unit.

[0539] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0540] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0541] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0542] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0543] In some embodiments, the group of first portions comprises a first portion including a composite coil, the composite coil configured to wirelessly receive wireless energy from an external wireless energy transmitter and wirelessly transmit wireless energy to a second wireless receiver in the second portion.

[0544] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0545] In some embodiments, the group of one or more first portions comprises a first portion of push buttons and / or capacitive buttons for controlling functions of the remote unit.

[0546] An external device configured to communicate with an implantable medical device when implanted in a patient is provided, the external device comprising at least one first wireless transceiver configured to communicate with the implantable medical device using a first network protocol to determine a distance between the external device and the implantable medical device, and at least one second wireless transceiver configured to communicate with the implantable medical device using a second network protocol to transfer data between the external device and the implantable medical device.

[0547] According to one embodiment, the first wireless transceiver comprises a UWB transceiver.

[0548] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of powering energy consuming components of the implantable medical device and charging the implantable energy storage unit.

[0549] According to one embodiment, the second network protocol is a standard network protocol, which may be one of the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0550] According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.

[0551] According to one embodiment, the external device is further configured to communicate with a second external device using said at least one wireless transceiver.

[0552] According to one embodiment, the external device is configured to determine the distance between the external device and the implantable medical device by determining the RSSI.

[0553] According to one embodiment, the communication range of the first network protocol is less than the communication range of the second network protocol.

[0554] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0555] According to one embodiment, the external device is configured to authenticate the implantable medical device if the determined distance between the external device and the implantable medical device is less than a predetermined threshold.

[0556] According to one embodiment, the external device is configured to enable data transfer between the external device and the implantable medical device after the implantable medical device has been authenticated.

[0557] According to one embodiment, the external device is one selected from a wearable external device and a handset.

[0558] An implantable medical device configured to communicate with an external device is provided, the implantable medical device comprising at least one first wireless transceiver configured to communicate with the external device using a first network protocol to determine a distance between the external device and the implantable medical device, and at least one second wireless transceiver configured to communicate with the external device using a second network protocol to transfer data between the external device and the implantable medical device.

[0559] According to one embodiment, the first wireless transceiver comprises a UWB transceiver.

[0560] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of powering energy consuming components of the implantable medical device and charging the implantable energy storage unit.

[0561] According to one embodiment, the second network protocol is a standard network protocol, such as selected from the list of a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0562] According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.

[0563] According to one embodiment, the implantable medical device is further configured to communicate with a second external device using the at least one wireless transceiver.

[0564] According to one embodiment, the implantable medical device is configured to determine the distance between the external device and the implantable medical device by determining the RSSI.

[0565] According to one embodiment, the communication range of the first network protocol is less than the communication range of the second network protocol.

[0566] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0567] According to one embodiment, the implantable medical device is configured to authenticate the external device if the determined distance between the external device and the implantable medical device is less than a predetermined threshold.

[0568] According to one embodiment, the implantable medical device is configured to allow transfer of data between the implantable medical device and the external device after the external device has been authenticated.

[0569] According to one embodiment, the implantable medical device comprises at least one of the following: external cardiac compression devices, a device that assists the pumping function of a patient's heart; a pump function assist device comprising a turbine bump placed in a patient's blood vessel to assist the pumping function of the heart; steerable prosthetic heart valves, an operable prosthetic heart valve to increase blood flow to the coronary arteries; implantable drug delivery devices, an implantable drug delivery device that can inject directly into blood vessels and relocate the injection site; an implantable drug delivery device for injecting an efficacy-enhancing drug into the patient's erectile tissue; Hydraulic, mechanical, and / or electrical contraction implants, an operable volumetric filling device; Operable cosmetic implants, manipulable cosmetic implants for adjusting the shape and / or size of a patient's breast area; implant-controlled medical devices for emptying the bladder; Implants to prevent urinary leakage implants to prevent anal incontinence, implants that control fecal excretion, implants to monitor aneurysms; implants to prevent the expansion of aneurysms; implants that lubricate joints, implants that affect blood flow to the patient's erectile tissue; implants to simulate erectile tissue expansion, Implants with reservoirs for storing bodily fluids; implants that store and / or empty internal or surgically created reservoirs; implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, Implants to treat impotence, An implant that controls the flow of eggs within the uterine canal, An implant that controls the flow of sperm within the uterine canal, An implant that controls the flow of sperm in the vas deferens, implants that block sperm transport in the vas deferens; implants to treat osteoarthritis, implants that test internal body parameters; implants that control specific treatment parameters from within the body; Implants that control body parameters from within the body, blood pressure control implants implants that control blood pressure by affecting the dilation of the renal arteries; implants that control drug treatment parameters; Implants that control blood parameters, implants for adjusting or replacing bone parts of the patient's body; Implants that replace a patient's organ or part of an organ or its function; vascular treatment equipment, implants that move fluid within a patient's body; an implant configured to sense a parameter associated with swallowing in a patient; an implant configured to exercise muscles by electrical or mechanical stimulation; an implant configured to empty a portion of the intestinal tract on command; an implant configured to compress the bladder to empty the bladder from within the patient; an implant configured to drain fluid from within a patient's body; an implant configured to apply lubricating fluid to the joint to actively lubricate it; an implant configured to remove blood clots and particles from a patient's bloodstream; an implant configured to lengthen or correct a patient's bone to reduce scoliosis; Brain stimulation devices, an implant configured to adjust the position of the female urethra or bladder neck; An implant configured to stimulate the vascular ampulla, causing temporary constriction.

[0570] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0571] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0572] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0573] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0574] A patient-external device is provided that is configured to communicate with an implantable medical device when implanted in a patient, the patient-external device comprising: a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and configured to wirelessly communicate with a patient display; and a computing unit configured to execute control software to generate control commands for operation of the implantable medical device. The computing unit is configured to transmit a control interface as a remote display portal to the patient display configured to display the control interface to a user, receive user input from the patient display, and convert the user input into control commands for wireless transmission to the implantable medical device.

[0575] According to one embodiment, the wireless communication unit comprises a wireless transceiver for wirelessly transmitting control commands to the implantable medical device and a control interface as a remote display portal to the patient display device.

[0576] According to one embodiment, the wireless communication unit comprises a first wireless transceiver for wirelessly transmitting control commands to the implantable medical device and a second wireless transceiver for wirelessly transmitting a control interface to the patient display device.

[0577] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient display device using standard network protocols.

[0578] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the implantable medical device using a proprietary network protocol.

[0579] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0580] According to one embodiment, at least one of the first and second wireless transceivers comprises a Bluetooth transceiver.

[0581] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0582] According to one embodiment, at least one of the first and second wireless transceivers comprises an UWB transceiver.

[0583] According to one embodiment, the wireless communication unit comprises at least one first wireless transceiver configured to communicate with the implantable medical device using a first network protocol to determine a distance between the patient-external device and the implantable medical device, and at least one second wireless transceiver configured to communicate with the implantable medical device using a second network protocol to transfer data between the patient-external device and the implantable medical device.

[0584] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of powering energy consuming components of the implantable medical device and charging the implantable energy storage unit.

[0585] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0586] According to one embodiment, the communication range of the first wireless transceiver is less than the communication range of the second wireless transceiver.

[0587] According to one embodiment, at least one of the following: the patient-external device is configured to authenticate the implantable medical device when a distance between the patient-external device and the implantable medical device is less than a predetermined threshold; the patient-external device is configured to be authenticated by the implantable medical device if the distance between the patient-external device and the implantable medical device is less than a predetermined threshold; the patient external device is configured to authenticate the patient display device when a distance between the patient external device and the patient display device is less than a predetermined threshold; and The patient-external device is configured to be authenticated by the implantable medical device if the distance between the patient-external device and the patient display device is less than a predetermined threshold.

[0588] According to one embodiment, the patient external device is configured to enable data transfer between the patient external device and at least one of the implantable medical device and the patient external device and the patient display device based on authentication.

[0589] According to one embodiment, the computing device is configured to encrypt at least one of the control interface and the control commands.

[0590] According to one embodiment, the implantable medical device comprises at least one of the following: external cardiac compression devices, a device that assists the pumping function of a patient's heart; a pump function assist device comprising a turbine bump placed in a patient's blood vessel to assist the pumping function of the heart; steerable prosthetic heart valves, A steerable artificial heart valve to increase blood flow to the coronary arteries.

[0591] implantable drug delivery devices, an implantable drug delivery device that can inject directly into blood vessels and relocate the injection site; an implantable drug delivery device for injecting an efficacy-enhancing drug into the patient's erectile tissue; Hydraulic, mechanical, and / or electrical contraction implants, an operable volumetric filling device; Operable cosmetic implants, manipulable cosmetic implants for adjusting the shape and / or size of a patient's breast area; implant-controlled medical devices for emptying the bladder; Implants to prevent urinary leakage implants to prevent anal incontinence, implants that control fecal excretion, implants to monitor aneurysms; implants to prevent the expansion of aneurysms; implants that lubricate joints, implants that affect blood flow to the patient's erectile tissue; implants to simulate erectile tissue expansion, Implants with reservoirs for storing bodily fluids; implants that store and / or empty internal or surgically created reservoirs; implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, Implants to treat impotence, An implant that controls the flow of eggs within the uterine canal, An implant that controls the flow of sperm within the uterine canal, An implant that controls the flow of sperm in the vas deferens, implants that block sperm transport in the vas deferens; implants to treat osteoarthritis, implants that test internal body parameters; implants that control specific treatment parameters from within the body; Implants that control body parameters from within the body, blood pressure control implants implants that control blood pressure by affecting the dilation of the renal arteries; implants that control drug treatment parameters; Implants that control blood parameters, implants for adjusting or replacing bone parts of the patient's body; Implants that replace a patient's organ or part of an organ or its function; vascular treatment equipment, implants that move fluid within a patient's body; an implant configured to sense a parameter associated with swallowing in a patient; an implant configured to exercise muscles by electrical or mechanical stimulation; an implant configured to empty a portion of the intestinal tract on command; an implant configured to compress the bladder to empty the bladder from within the patient; an implant configured to drain fluid from within a patient's body; an implant configured to apply lubricating fluid to the joint to actively lubricate it; an implant configured to remove blood clots and particles from a patient's bloodstream; an implant configured to lengthen or correct a patient's bone to reduce scoliosis; Brain stimulation devices, an implant configured to adjust the position of the female urethra or bladder neck; An implant configured to stimulate the vascular ampulla, causing temporary constriction.

[0592] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0593] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0594] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0595] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0596] A patient display device for communicating with a patient remote external device for communicating with an implantable medical device is provided, the patient display device comprising: a wireless communication unit configured to wirelessly receive an implant control interface as a remote display portal from the patient remote external device and configured to wirelessly transmit implant control user input to the patient remote external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from a user.

[0597] According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit configured to be disabled to enable at least one of wirelessly receiving the implant control interface as a remote display portal from the patient remote external device and wirelessly transmitting implant control user inputs to the patient remote external device.

[0598] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient remote external device using a standard network protocol, which may be one of the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0599] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient remote external device using a proprietary network protocol.

[0600] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0601] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0602] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0603] According to one embodiment, the patient display device is configured to authenticate the patient remote external device when the distance between the patient display device and the patient remote external device is less than a predetermined threshold, or to be authenticated by the patient remote external device when the distance between the patient display device and the patient remote external device is less than a predetermined threshold.

[0604] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and the patient remote external device based on authentication.

[0605] According to one embodiment, the patient display device is a wearable external device or a handheld device.

[0606] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0607] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0608] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0609] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0610] A communication system is provided that enables communication between a patient display device and an implantable medical device at the time of implantation, the communication system comprising: a patient display device; a server and a patient remote external device. The patient display device includes a wireless communication unit configured to wirelessly receive an implant control interface as a remote display portal provided by the patient remote external device. The wireless communication unit is further configured to wirelessly transmit implant control user inputs intended for the patient remote external device to the server. The system further includes a display for displaying the received remote display portal and an input device for receiving implant control inputs from a user, and the patient remote external device includes a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and a computing device. The computing device is configured to execute control software for generating control commands for operation of the implantable medical device, transmit the control interface to the patient display device, receive implant control user inputs generated at the patient display device from the server, and convert the user inputs into control commands for wireless transmission to the implantable medical device.

[0611] According to one embodiment, the computing device is configured to encrypt at least one of the control interface and the control commands.

[0612] According to one embodiment, the patient display device is configured to encrypt user input.

[0613] According to one embodiment, the server is configured to encrypt at least one of user input received from the patient display device and control interface received from the patient remote external device.

[0614] According to one embodiment, the computing device is configured to encrypt the control interface and the patient display device is configured to decrypt the encrypted control interface.

[0615] According to one embodiment, the server is configured to act as a router and forward encrypted control interfaces from the patient remote external device to the patient display device without decrypting them.

[0616] According to one embodiment of the communication system or patient display device, the implantable medical device comprises at least one of the following: implant-controlled medical devices for emptying the bladder; Implants to prevent urinary leakage implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, an implant configured to compress the bladder to empty the bladder from within the patient; According to one embodiment, the communication system further comprises a server. The server may comprise a wireless communication unit configured to wirelessly receive the implant control interface received from the patient remote external device and wirelessly transmit the implant control interface to the patient display device as a remote display portal. The wireless communication unit is further configured to wirelessly receive the implant control user input from the patient EID external device and wirelessly transmit the implant control user input to the patient display device.

[0617] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0618] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0619] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0620] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0621] A patient-external device for communicating with an implantable medical device and a patient display device for communication at the time of implantation are provided. The patient display device includes a wireless communication unit, a display, and an input device for receiving implant control inputs from a user. The patient display device is configured to execute a first application for wireless communication with a server and / or a DDI and a second application for wireless communication with the patient external device for transmitting the implant control inputs to a remote display portal of the patient external device for communication with the implantable medical device, the second application being configured to be accessed via the first application. The patient display device includes a first login function and a second login function, the first login function allowing a user to access the first application, and a combination of the first and second login functions allowing the user to access the second application. The first login function can be configured to use at least one of a password, a pin code, a fingerprint, voice, and face authentication. The second login function in the first application is configured to authenticate a second hardware key of the patient external device for a defined period of time using a secret key from the user.

[0622] According to one embodiment, the initial login is a PIN-based login.

[0623] According to one embodiment, at least one of the first and second logins is a login based on biometric input or a hardware key.

[0624] According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit, the auxiliary wireless communication unit configured to be disabled to enable wireless communication with the patient-external device.

[0625] According to one embodiment, the patient display device is configured to wirelessly receive the implant control interface from the patient external device as a remote display portal that is displayed on the display.

[0626] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using standard network protocols.

[0627] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using a proprietary network protocol.

[0628] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using a first network protocol and to wirelessly communicate with the server using a second network protocol.

[0629] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using a first frequency band and to wirelessly communicate with the server using a second frequency band.

[0630] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0631] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0632] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0633] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0634] According to one embodiment, the wireless communication unit comprises a first wireless transceiver for communicating with a patient-external device and a second wireless transceiver for communicating with a server.

[0635] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0636] According to one embodiment, the patient display device is configured to authenticate the patient external device when the distance between the patient display device and the patient external device is less than a predetermined threshold, or to be authenticated by the patient external device when the distance between the patient display device and the patient external device is less than a predetermined threshold.

[0637] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and the external patient device based on authentication.

[0638] According to one embodiment, the patient display device is a wearable external device or a handheld device.

[0639] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0640] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0641] According to one embodiment, the second application is configured to receive data regarding parameters relating to at least one of battery status, temperature, time, and errors.

[0642] According to one embodiment, the patient display device is configured to encrypt user input.

[0643] According to one embodiment, the display is configured to encrypt user input for decoding by the implantable medical device.

[0644] According to one embodiment, the patient display device is configured to decode the control interface received from the patient external device and display the control interface on the display.

[0645] According to one embodiment, at least one of the first and second applications is configured to receive data from the auxiliary external device and present the received data to a user.

[0646] According to one embodiment, at least one of the first and second applications is configured to receive data from an auxiliary external device that includes a weight scale for measuring the weight of the user.

[0647] According to one embodiment, at least one of the first and second applications is configured to receive data relating to the user's weight from an auxiliary external device comprising a weight scale.

[0648] According to one embodiment, the patient display device is configured to wirelessly transmit data regarding the user's weight to the patient external device, wirelessly transmit instructions derived from the data regarding the user's weight, or wirelessly transmit instructions derived from a combination of the data regarding the user's weight and implant control inputs received from the user.

[0649] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0650] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0651] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0652] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0653] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0654] A communication system is provided that, when implanted, enables communication between a patient display device and an implantable medical device. The communication system comprises a patient display device: a server or DDI and a patient remote external device. The patient display device comprises a wireless communication unit configured to wirelessly receive an implant control interface as a remote display portal from the patient remote external device, the wireless communication unit further configured to wirelessly transmit implant control user input to the patient remote external device and comprising a display for displaying the received implant control interface as the remote display portal and an input device for receiving the implant control input from a user. The patient display device is configured to execute a first application for wireless communication with the server and a second application for wireless communication with the patient remote external device for transmitting the implant control input to the remote display portal of the patient remote external device for communication with the implantable medical device. The patient remote external device is configured to wirelessly transmit control commands to the implantable medical device based on the implant control input and comprises a wireless communication unit configured to wirelessly communicate with the patient display device.

[0655] According to one embodiment, the patient display device includes a first login function and a second login function, the first login function allowing a user to access a first application, and the combination of the first and second login functions allowing a user to access a second application.

[0656] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0657] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0658] According to one embodiment, the second application is configured to receive data relating to parameters relating to at least one of the following: Temperature, time, error.

[0659] According to one embodiment, the patient display device is configured to encrypt user input.

[0660] According to one embodiment, the display is configured to encrypt user input for decoding by the implantable medical device.

[0661] According to one embodiment, the patient remote external device is configured to act as a router to forward encrypted user input from the patient display device to the implantable medical device without decrypting it.

[0662] According to one embodiment, the patient remote external device is configured to encrypt at least one of the control interface and the control commands.

[0663] According to one embodiment, the patient remote external device is configured to encrypt the control interface and the patient display device is configured to decrypt the encrypted control interface.

[0664] There is provided a computer program product configured to run on a patient display device comprising a wireless communication unit, a display for displaying a received implant control interface as a remote viewing portal, and an input device for receiving implant control input from a user, the computer program product comprising: The first application to communicate with the server or DDI, a second application for communication with the patient remote external device for transmitting implant control inputs via a remote display portal of the patient remote external device for communication with the implantable medical device, the second application being configured to be accessed via the first application; The primary login function is to use at least one of the following: password, pin code, fingerprint, or face recognition. a second login function within the first application that authenticates a second hardware key of the patient remote external device for a defined period of time using a private key from the user, the first login function allowing the user to access the first application, and the combination of the first and second login functions allowing the user to access the second application.

[0665] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0666] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0667] According to one embodiment, the second application is configured to receive data relating to parameters relating to at least one of the following: Temperature, time, error.

[0668] According to one embodiment of the communication system, patient display device or computer program product, the implantable medical device comprises at least one of the following: external cardiac compression devices, a device that assists the pumping function of a patient's heart; a pump function assist device comprising a turbine bump placed in a patient's blood vessel to assist the pumping function of the heart; steerable prosthetic heart valves, A steerable artificial heart valve to increase blood flow to the coronary arteries.

[0669] implantable drug delivery devices, an implantable drug delivery device that can inject directly into blood vessels and relocate the injection site; an implantable drug delivery device for injecting an efficacy-enhancing drug into the patient's erectile tissue; Hydraulic, mechanical, and / or electrical contraction implants, an operable volumetric filling device; surgical gastric band, an operable implant for stretching the patient's stomach wall to produce a feeling of satiety; an implant configured to sense the frequency with which the patient consumes food; Operable cosmetic implants, manipulable cosmetic implants for adjusting the shape and / or size of a patient's breast area; implant-controlled medical devices for emptying the bladder; Implants to prevent urinary leakage implants to prevent anal incontinence, implants that control fecal excretion, implants to monitor aneurysms; implants to prevent the expansion of aneurysms; implants that lubricate joints, implants that affect blood flow to the patient's erectile tissue; implants to simulate erectile tissue expansion, Implants with reservoirs for storing bodily fluids; implants that store and / or empty internal or surgically created reservoirs; implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, Implants to treat impotence, An implant that controls the flow of eggs within the uterine canal, An implant that controls the flow of sperm within the uterine canal, An implant that controls the flow of sperm in the vas deferens, implants that block sperm transport in the vas deferens; implants to treat osteoarthritis, implants that test internal body parameters; implants that control specific treatment parameters from within the body; Implants that control body parameters from within the body, blood pressure control implants implants that control blood pressure by affecting the dilation of the renal arteries; implants that control drug treatment parameters; Implants that control blood parameters, implants for adjusting or replacing bone parts of the patient's body; Implants that replace a patient's organ or part of an organ or its function; vascular treatment equipment, implants that move fluid within a patient's body; an implant configured to sense a parameter associated with swallowing in a patient; an implant configured to exercise muscles by electrical or mechanical stimulation; an implant configured to empty a portion of the intestinal tract on command; a maneuverable implant configured to be inserted into the patient's stomach to reduce the volume of the stomach substantially below the volume of the device; an implant configured to compress the bladder to empty the bladder from within the patient; an implant configured to drain fluid from within a patient's body; an implant configured to apply lubricating fluid to the joint to actively lubricate it; an implant configured to remove blood clots and particles from a patient's bloodstream; an implant configured to lengthen or correct a patient's bone to reduce scoliosis; Brain stimulation devices, An artificial stomach that replaces the functions of a natural stomach an implant configured to adjust the position of the female urethra or bladder neck; An implant configured to stimulate the vascular ampulla, causing temporary constriction.

[0670] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, with the HCP or HCP administrator having such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices to the system via the HCP EID external device.

[0671] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0672] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0673] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0674] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0675] A communication system is provided that enables communication between a patient display device, a patient external device, a server, and an implantable medical device. The communication system comprises a server: A patient display, a patient external device, and an implantable medical device. The patient display includes a wireless communication unit for wirelessly communicating with at least one of the patient external device and a server, a display, and an input device for receiving input from a user. The patient external device includes a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and configured to wirelessly communicate with at least one of the patient display and the server. The server further includes a wireless communication unit configured to wirelessly communicate with at least one of the patient display and the patient external device, and the implantable medical device includes a wireless communication unit configured to wirelessly communicate with the patient external device. The implantable medical device further includes an encryption unit configured to: encrypt data destined for the server and transmit the data to the server via the patient external device, with the patient external device acting as a router forwarding the data without full decryption. In one embodiment, the implantable medical device includes the encryption unit and is configured to encrypt data destined for the patient display and transmit the data to the patient display via the patient external device, with the patient external device acting as a router forwarding the data without full decryption. In one embodiment, the server comprises an encryption unit and is configured to: encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the patient-external device, with the patient-external device acting as a router to forward the data without full decryption; encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the patient display and the patient external device, with the patient display and the patient external device acting as a router to forward the data without full decryption. In one embodiment, the patient display comprises an encryption unit and is configured to encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the patient external device, with the patient external device acting as a router to forward the data without full decryption. In one embodiment, the patient display comprises an encryption unit and is configured to encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the server and the patient external device, with the server and the patient external device acting as routers to forward the data without full decryption.

[0676] According to one embodiment, the patient display device is configured to wirelessly receive from the patient external device the implant control interface to be displayed on the display.

[0677] According to one embodiment, at least two of the wireless communication unit of the server, the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device are configured for wireless communication using a standard network protocol.

[0678] According to one embodiment, at least two of the wireless communication unit of the server, the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device are configured for wireless communication using a proprietary network protocol.

[0679] According to one embodiment, the wireless communication unit of the patient external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the server, or to use the first network protocol for communication with the implantable medical device and the second network protocol for communication with the patient display device.

[0680] According to one embodiment, the wireless communication unit of the patient external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the server, or to use the first frequency band for communication with the implantable medical device and the second frequency band for communication with the patient display device.

[0681] According to one embodiment, the wireless communication unit of the patient display device is configured to use a first network protocol for communication with the external patient device and a second network protocol for communication with the server.

[0682] According to one embodiment, the wireless communication unit of the patient display device is configured to use a first frequency band for communication with the external patient device and a second frequency band for communication with the server.

[0683] According to one embodiment, the wireless communication unit of the server is configured to use a first network protocol for communication with the patient-external device and a second network protocol for communication with the patient display device.

[0684] According to one embodiment, the wireless communication unit of the server is configured to use a first frequency band for communication with the patient-external device and a second frequency band for communication with the patient display device.

[0685] According to one embodiment, the wireless communication unit of at least one of the server, the patient display device, the patient external device, and the implantable medical device comprises a Bluetooth transceiver.

[0686] According to one embodiment, the wireless communication unit of at least one of the server, the patient display device, the patient external device, and the implantable medical device comprises a UWB transceiver.

[0687] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0688] According to one embodiment, the wireless communication unit of the patient-external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the server, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0689] According to one embodiment, the wireless communication unit of the patient-external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the patient display device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0690] According to one embodiment, the wireless communication unit of the patient display device comprises a first wireless transceiver for wireless communication with the patient external device and a second wireless transceiver for wireless communication with the server, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0691] According to one embodiment, the second wireless transceiver has one of the following ranges: 2x, 4x, 8x, 20x, 50x, or 100x.

[0692] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0693] According to one embodiment, at least one of the following: the patient display device is configured to authenticate the patient external device when a distance between the patient display device and the patient external device is less than a predetermined threshold; the patient display device is configured to be authenticated by the patient external device if the distance between the patient display device and the patient external device is less than a predetermined threshold; the patient display device is configured to authenticate the implantable medical device when a distance between the patient display device and the implantable medical device is less than a predetermined threshold; the patient display device is configured to be authenticated by the implantable medical device when the distance between the patient display device and the implantable medical device is less than a predetermined threshold; the patient external device is configured to authenticate the patient display device when a distance between the patient external device and the patient display device is less than a predetermined threshold; the patient external device is configured to be authenticated by the patient display device if the distance between the patient external device and the patient display device is less than a predetermined threshold; the patient-external device is configured to authenticate the implantable medical device when a distance between the patient-external device and the implantable medical device is less than a predetermined threshold; and The patient-external device is configured to be authenticated by the implantable medical device if the distance between the patient-external device and the implantable medical device is less than a predetermined threshold.

[0694] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and the external patient device based on authentication.

[0695] According to one embodiment, the patient external device is configured to allow data transfer between the patient display device and the patient external device based on authentication.

[0696] According to one embodiment, the patient-external device is configured to enable data transfer between the patient-external device and the implantable medical device based on authentication.

[0697] According to one embodiment, the patient display device is a wearable external patient device or a handheld device.

[0698] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0699] There is provided a server for use in a communication system according to any one of the above embodiments.

[0700] There is provided a patient display device for use in a communication system according to any one of the above embodiments.

[0701] There is provided a patient external device for use in a communication system according to any one of the above embodiments.

[0702] There is provided an implantable medical device for use in a communication system according to any one of the above embodiments.

[0703] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0704] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0705] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0706] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0707] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0708] A system configured to remotely change preprogrammed therapy settings of an implantable medical device implanted in a patient is provided. The system comprises at least one healthcare provider (HCP), an EID external device, and an HCP private key device. The HCP EID external device is adapted to receive commands from the HCP to change the preprogrammed therapy settings of the implanted medical device and is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing the HCP private key device, the HCP private key device being adapted to be provided to the HCP EID external device via at least one of an HCP private key device read slot or equivalent, RFID communication, or other near-field wireless activation communication. The HCP EID external device comprises at least one of an HCP private key device read slot or equivalent, RFID communication, other near-field wireless activation communication, or direct electrical contact. The HCP EID external device further comprises at least one wireless transceiver configured to communicate with a data infrastructure server (DDI) via a first network protocol.The system further includes a data infrastructure server DDI adapted to receive commands from the HCP EID external device and relay the received commands to a patient EID external device without modifying the commands, the DDI comprising a wireless transceiver configured to communicate with the patient external device and a patient EID external device adapted to receive the commands relayed by the DDI, the implanted medical device further adapted to transmit the commands to the implanted medical device, and further adapted to receive commands from the HCP EID external device via the DDI to modify the preprogrammed therapy settings of the implanted medical device, the implanted medical device further adapted to be activated, authenticated, and authorized to execute the commands by the patient providing at least one of a patient private key device adapted to be provided by the patient to the patient EID external device by: a patient private key device read slot or equivalent, RFID communication or other near-field wireless activation communication, or direct electrical contact. The patient EID external device is configured with at least one of an HCP private key device read slot or equivalent, RFID communication, other near-field wireless activation communication, or direct electrical contact. The patient EID external device further comprises at least one wireless transceiver configured to communicate with the implantable medical device via a second network protocol, and the implanted medical device is further configured to treat the patient or perform a bodily function.

[0709] According to one embodiment, at least one of the patient private key device or the HCP private key device comprises a hardware key.

[0710] According to one embodiment, the private key device is at least one of a smart card, a key ring device, a watch, an arm or wrist band, a necklace, or any shaped device.

[0711] According to one embodiment of the system, at least two of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI are configured for wireless communication using a standard network protocol.

[0712] According to one embodiment, at least two of the HCP EID external device, the patient EID external device, the HCP Private Key device, the patient Private Key device, and the DDI are configured for wireless communication using a proprietary network protocol.

[0713] According to one embodiment, the patient EID external device is configured to use a first network protocol to communicate with the implantable medical device and a second network protocol to communicate with the DDI.

[0714] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the DDI.

[0715] According to one embodiment, the DDI is configured to use a first frequency band for communication with the patient EID external device and a second frequency band for communication with the patient private key device.

[0716] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI includes a Bluetooth transceiver.

[0717] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI comprises a UWB transceiver.

[0718] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0719] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the DDI, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0720] According to one embodiment, the patient private key device includes a first wireless transceiver for wirelessly communicating with the HCP EID external device and a second wireless transceiver for wirelessly communicating with the DDI, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0721] According to one embodiment, the second wireless transceiver has an effective range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0722] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0723] According to one embodiment, the patient EID external device is configured to enable data transfer between the EID external device and the implantable medical device based on authentication of the patient EID external device.

[0724] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0725] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0726] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, with the HCP or HCP administrator having such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices to the system via the HCP EID external device.

[0727] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0728] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0729] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0730] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0731] A system configured to change preprogrammed therapy settings of an implantable medical device by a healthcare provider (HCP) in the patient's physical presence when the device is implanted in a patient is provided. The system includes at least one HCP EID external device adapted to receive commands, directly or indirectly, from the HCP to change the preprogrammed therapy settings of the implantable medical device when the device is implanted. The HCP EID external device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP private key device comprising an HCP private key. The HCP private key device may comprise at least one of a smart card, a keychain device, a watch, a wristband, a necklace, and any shape of device. The HCP EID external device is adapted to participate in at least one of receiving information from the implant, receiving information from a patient remote external device, activating the implanted medical device, changing the preprogrammed settings, and updating the software of the implanted medical device. The HCP EID external device is further adapted to be activated, authenticated, and authorized to execute the commands by the patient. The system further includes a patient private key device including a patient private key, the patient private key device including at least one of a smart card, a key fob device, a watch, a wrist or arm band, a necklace, and a device of any shape. The HCP private key and the patient private key are necessary for the HCP EID external device to perform at least one of the following operations when the implantable medical device is implanted: receive information from the implantable medical device, receive information from the patient remote external device, activate the implantable medical device, change preprogrammed settings, and update software on the implantable medical device.

[0732] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0733] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, and a near-field wireless activation communication unit, or direct electrical contact.

[0734] According to one embodiment, the HCP EID external device comprises at least one read slot or equivalent for the HCP private key device, RFID communication and short-range radio-activated communication units, or direct electrical contact.

[0735] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0736] According to one embodiment, at least two of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device are configured for wireless communication using a standard network protocol.

[0737] According to one embodiment, at least two of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device are configured for wireless communication using a proprietary network protocol.

[0738] According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the patient private key device.

[0739] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the patient private key device.

[0740] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device comprises a Bluetooth transceiver.

[0741] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device comprises a UWB transceiver.

[0742] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0743] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the patient private key device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0744] According to one embodiment, the second wireless transceiver has an effective range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0745] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0746] According to one embodiment, the patient EID external device is configured to enable data transfer between the EID external device and the implantable medical device based on authentication of the patient EID external device.

[0747] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0748] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0749] A system configured to change a preprogrammed and preselected therapy operation of an implantable medical device implanted in a patient based on a patient's command is provided. The system includes the implantable medical device, a patient remote external device, a wireless transceiver configured to communicate with the implantable medical device via a second network protocol when the medical device is implanted, and a remote display portal. The remote display portal is configured to receive content delivered from the patient remote external device and expose a button for the patient to indicate their intent to activate a function of the implantable medical device through the patient remote external device, and further configured to remotely present on the patient display device a display portal that enables the patient to activate a function of the implantable medical device through the display portal of the patient remote external device visualized on the patient display device.

[0750] According to one embodiment, the wireless transceiver, the remote viewing portal, and the remote viewing portal are configured within a patient remote external device.

[0751] According to one embodiment, the system further comprises a patient display device, which may include a display hosting the assistance application, a remote display portal, and a patient display device private key.

[0752] According to one embodiment, the remote display portal can generate commands that are signed with the private key of the patient display device.

[0753] According to one embodiment, the patient remote external device is adapted to accept input from the patient via said patient display device via its remote display portal.

[0754] According to one embodiment, the patient remote external device comprises a graphical user interface disposed on a touch-responsive display exposing buttons representing operational functions of the implanted medical device.

[0755] According to one embodiment, the system is configured to allow the patient to activate the implant at home through a patient remote external device with authorization granted by the patient private key.

[0756] According to one embodiment, the patient private key is configured on at least one of a smart card, a key fob device, a watch, a wrist or wristband, a necklace, and a device of any shape.

[0757] According to one embodiment, the system is configured to allow a patient, when implanted, to operate the implantable medical device at home through a patient remote external device using authorization granted by the patient private key.

[0758] According to one embodiment, the system further comprises a patient EID external device that includes at least one of a read slot or equivalent for a patient private key device, RFID communication, near-field wireless activation communication, or direct electrical contact.

[0759] According to one embodiment, the patient EID external device is adapted to synchronize with the patient remote external device.

[0760] According to one embodiment, the patient EID external device further comprises at least one of a patient, a wireless transceiver configured to communicate with the remote external device, and a wired connector for communicating with the patient remote external device.

[0761] According to one embodiment, the patient EID external device is adapted to generate an authorization signed by a patient private key installed in at least one of the patient remote external device and the implantable medical device via the patient EID external device.

[0762] According to one embodiment, the system includes a patient display device that includes an assistance application capable of displaying a remote viewing portal with content delivered from a patient remote external device.

[0763] According to one embodiment, the remote viewing portal and the patient remote external device are adapted to expose a button for the patient to indicate intent to activate a function of the implantable medical device through the patient remote external device.

[0764] According to one embodiment, the patient display device comprises at least one of a display hosting the remote display portal and a private key for the patient display device.

[0765] According to one embodiment, the Remote Display Portal can generate commands that are signed with a patient private key.

[0766] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0767] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0768] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0769] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0770] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0771] A system configured to remotely provide information from an implantable medical device implanted in a patient to the patient is provided. The system includes at least one patient EID external device adapted to receive information from the implant and further adapted to transmit such information to a server or dedicated data infrastructure (DDI), and further adapted to be activated and authenticated by the implantable medical device and authorized to receive the information by the patient providing a private key. The system further includes a patient private key device including a private key adapted to be provided to the patient EID external device via at least one of a patient private key device read slot or equivalent, RFID communication or other near-field wireless activation communication, or direct electrical connection. The patient EID external device is configured with at least one of a patient private key device read slot or equivalent, RFID communication, other near-field wireless activation communication, or direct electrical contact. The patient EID external device further includes at least one wireless transceiver configured to communicate with the DDI via a first network protocol.

[0772] According to one embodiment, the at least one patient EID external device is adapted to receive information from the implant via a second network protocol.

[0773] According to one embodiment, the system comprises a DDI adapted to receive information from said patient EID external device, the DDI comprising a wireless transceiver configured to communicate with said patient EID external device.

[0774] According to one embodiment, the patient EID external device is adapted to receive commands relayed by the DDI, and is adapted to further send commands to the implanted medical device to change the pre-programmed therapy settings of the implanted medical device, and is further adapted to be activated, authenticated, and authorized to execute said commands by the patient providing a patient private key.

[0775] According to one embodiment, the patient private key device is adapted for the patient to provide the patient private key to the patient EID external device via at least one of a patient private key device read slot or equivalent, RFID communication or other near-field wirelessly activated communication, or direct electrical contact.

[0776] According to one embodiment, the patient EID external device includes at least one of a read slot or equivalent for an HCP private key device, RFID communication, other near-field wirelessly initiated communication, or direct electrical contact.

[0777] According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0778] According to one embodiment, the system comprises an implantable medical device that, when implanted, is adapted to treat a patient or perform a bodily function.

[0779] According to one embodiment, the patient private key is configured on at least one of a smart card, a key fob device, a watch, a bracelet or wristband, a necklace, and a device of any shape.

[0780] According to one embodiment, at least two of the patient EID external device, the IDD, and the patient private key device are configured for wireless communication using standard network protocols.

[0781] According to one embodiment, at least two of the patient EID external device, the IDD, and the patient private key device are configured for wireless communication using a proprietary network protocol.

[0782] According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the patient private key device.

[0783] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the patient private key device.

[0784] According to one embodiment, at least one of the patient EID external device, the patient private key device, and the IDD comprises a Bluetooth transceiver.

[0785] According to one embodiment At least one of the patient EID external device, the patient private key device and the IDD comprises a UWB transceiver.

[0786] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0787] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the patient private key device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0788] According to one embodiment, the second wireless transceiver has an effective range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0789] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0790] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0791] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0792] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, with the HCP or HCP administrator having such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices to the system via the HCP EID external device.

[0793] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0794] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0795] According to one embodiment, the system includes a measurement device or sensor adapted to send measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0796] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0797] A system is provided comprising: an implantable medical device adapted, when implanted in a patient, to communicate with an external device, the external device including at least one of a patient remote external device or a patient EID external device. The system further comprises a patient EID external device adapted, when implanted, to communicate with the implantable medical device, send commands to the implantable medical device, and change preprogrammed settings therein; and a patient private key device including a patient private key adapted to activate, authenticate, and execute the commands by the patient EID external device, the private key being adapted to be provided to the external device via at least one of an HCP private key device read slot or equivalent, RFID communication or other near-field wireless activation communication, or direct electrical contact. The system further comprises a data infrastructure server (DDI) adapted to send a command to the patient EID external device to disable the authorization and authentication functions of the patient private key for further transmission to the implantable medical device.

[0798] According to one embodiment, at least one patient remote external device includes a patient remote external device private key, and a DDI via the patient EID external device can deactivate the authorization and authentication functions of the patient remote external device, thereby deactivating the patient remote external device.

[0799] According to one embodiment, the patient EID external device comprises at least one wireless transceiver configured to communicate with the DD1 via a first network protocol.

[0800] According to one embodiment, the system comprises a DDI adapted to receive commands from an HCP EID external device and transmit the received commands to a patient EID external device, the DDI comprising a wireless transceiver configured to communicate with said patient external device.

[0801] According to one embodiment, the patient EID external device is adapted to receive a command from the DDI, the command originating from a healthcare provider (HCP), and the patient EID is adapted to deactivate the patient private key and send the command to the implanted medical device.

[0802] According to one embodiment, the patient EID external device is adapted to receive a command from the DDI, the command originating from a healthcare provider (HCP), the patient EID external device is adapted to receive a command from the HCP via the DDI to deactivate the patient remote external device comprising a patient remote external device private key, and the patient EID external device is further adapted to transmit the command to the implanted medical device.

[0803] According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0804] According to one embodiment, at least one of the patient private key and the patient remote external device private key comprises a hardware key.

[0805] According to one embodiment, the private key device is at least one of a smart card, a key ring device, a watch, an arm or wrist band, a necklace, or any shaped device.

[0806] According to one embodiment, at least two of the patient remote external device, the patient EID external device, the patient private key device, and the DDI are configured for wireless communication using standard network protocols.

[0807] According to one embodiment, at least two of the patient remote external device, the patient EID external device, the patient private key device, and the DDI are configured for wireless communication using a proprietary network protocol.

[0808] According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the patient private key device.

[0809] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the patient private key device.

[0810] According to one embodiment, at least one of the patient remote external device, the patient EID external device, the patient private key device, and the DDI comprises a Bluetooth transceiver.

[0811] According to one embodiment, at least one of the patient remote external device, the patient EID external device, the patient private key device, and the DDI comprises a UWB transceiver.

[0812] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0813] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the patient private key device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0814] According to one embodiment, the second wireless transceiver has an effective range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0815] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0816] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0817] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0818] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to allow the exchange and pairing of new patient private key devices or HCP private key devices into the system via an HCP EID external device.

[0819] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0820] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0821] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0822] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0823] A system is provided that allows a healthcare provider (HCP) to change preprogrammed therapy settings in an implantable medical device step when implanted in a patient, either in the patient's physical presence or remotely from the patient. The system includes at least one HCP EID external device adapted to receive commands directly or indirectly from the HCP to change the preprogrammed therapy settings in the implantable medical device step when implanted. The HCP EID external device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP private key device comprising an HCP private key. The HCP private key comprises at least one of a smart card, a key fob device, a watch, a wrist or wrist band, a necklace, and a device of any shape. The system further includes a patient private key device that includes the patient private key, the patient private key device comprising at least one of a smart card, a key fob device, a watch, a wrist or arm band, a necklace, and a device of any shape. Both the HCP Private Key and the Patient Private Key are required to perform the actions by the HCP EID external device to change settings preprogrammed into the implantable medical device when the implantable medical device is implanted and to update the implantable medical device's software. The Patient Private Key is adapted to initiate, authenticate, and authorize execution of the commands provided by the HCP via the HCP EID external device or when actions are performed remotely via the Patient EID external device.

[0824] According to one embodiment, the system includes a master private key device that allows for the issuance of new private key devices, and an HCP or HCP administrator, via an HCP EID external device, exchanges new patient private key devices or HCP private key devices and adapts such master private key devices so that they can be paired to the system.

[0825] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0826] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0827] According to one embodiment, the system further comprises a measurement device or sensor adapted to provide measurements to at least one of the DDI, the patented EID external device, and the patient display device.

[0828] According to one embodiment, the system further comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being configured to be connected to a control unit of the medical device so as to trigger a stomach stretching action after ingestion of a determined amount of food.

[0829] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0830] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, and a near-field wireless activation communication unit, or direct electrical contact.

[0831] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent of the HCP private key device, RFID communication, a short-range wireless activated communication unit, or direct electrical contact.

[0832] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0833] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0834] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.

[0835] According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the HCP private key device.

[0836] According to one embodiment, the HCP EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the HCP private key device.

[0837] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0838] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0839] A system configured to allow a healthcare provider (HCP) to remotely change preprogrammed therapy settings in an implantable medical device upon implantation in a patient, the system comprising at least one HCP EID external device adapted to receive commands directly or indirectly from the HCP to change the preprogrammed therapy settings in the implantable medical device upon implantation, the HCP EID external device further adapted to be activated, authenticated, and authorized to execute the commands by the HCP. Actions by the HCP EID external device to change the preprogrammed settings and update software in the implantable medical device upon implantation are adapted to be authenticated by an HCP private key device and a patient private key device.

[0840] According to one embodiment, the HCP private key device for configuring the HCP private key comprises at least one of a smart card, a key fob device, a watch, a wrist or wristband, a necklace, and a device of any shape.

[0841] According to one embodiment, the patient private key device comprises a patient private key comprising at least one of a smart card, a key fob device, a watch, a wrist or wristband, a necklace, and a device of any shape.

[0842] According to one embodiment, the patient private key is adapted to initiate, authenticate, and execute said commands provided by the HCP via the HCP EID external device or when actions are performed remotely via the patient EID external device.

[0843] According to one embodiment, the system further comprises a dedicated data infrastructure, a DDI, a patient EID external device, and an HCP EID external device, wherein communication between the patient EID external device and the HCP EID external device is via the DDI.

[0844] According to one embodiment, the system comprises a master private key device that enables the issuance of new private key devices, and the HCP or HCP administrator has such master private key device adapted to allow new patient private key devices or HCP private key devices to be replaced and paired with the system.

[0845] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0846] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0847] According to one embodiment, the system further comprises a measurement device or sensor adapted to provide measurements to at least one of the DDI, the patent EID external device, and the patient display device.

[0848] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient swallows solids or drinks liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0849] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0850] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, and a near-field wireless activation communication unit, or direct electrical contact.

[0851] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent of the HCP private key device, RFID communication, a short-range wireless activated communication unit, or direct electrical contact.

[0852] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0853] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0854] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.

[0855] According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the HCP private key device.

[0856] According to one embodiment, the HCP EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the HCP private key device.

[0857] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0858] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0859] A system configured to change preprogrammed therapy settings of an implantable medical device implanted in a patient from a remote location remote from the patient is provided. The system includes at least one healthcare provider (HCP) external device adapted to receive commands from an HCP to change the preprogrammed therapy settings of the implantable medical device. The HCP external device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP private key device adapted to be provided to the HCP EID external device via at least one of an HCP private key device read slot or equivalent, RFID communication, other short-range wireless activation communication, or direct electrical contact. The HCP EID external device further includes at least one wireless transceiver configured to communicate with the patient EID external device via a first network protocol. The system includes a patient EID external device adapted to receive commands from the HCP-external device and relay the received commands to the implantable medical device without modifying the commands, the patient EID external device having a wireless transceiver configured to communicate with the patient-external device, the patient EID external device adapted to send commands to the implantable medical device and to receive commands from an HCP to change the preprogrammed therapy settings of the implantable medical device, and further adapted to be activated and authenticated by a patient providing a patient private key device comprising a patient private key and authorized to execute the commands.

[0860] According to one embodiment, at least one of the patient private key device or the HCP private key device comprises a hardware key.

[0861] According to one embodiment, the private key device is at least one of a smart card, a key ring device, a watch, an arm or wrist band, a necklace, or any shaped device.

[0862] According to one embodiment, the system includes a master private key device that allows for the issuance of new private key devices, and an HCP or HCP administrator, via an HCP EID external device, exchanges new patient private key devices or HCP private key devices and adapts such master private key devices so that they can be paired to the system.

[0863] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0864] According to one embodiment, the HCP dedicated device and the HCP EID external device are integrated.

[0865] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0866] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient swallows solids or drinks liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0867] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0868] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, a near field wireless activation communication unit, or direct electrical contact.

[0869] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent of the HCP private key device, RFID communication, a short-range wireless activated communication unit, or direct electrical contact.

[0870] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0871] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0872] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.

[0873] According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the HCP private key device.

[0874] According to one embodiment, the HCP EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the HCP private key device.

[0875] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0876] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0877] The term "body tissue" as referred to in this disclosure may refer to one or more body tissue groups or layers of a patient, such as muscle tissue, connective tissue, bone, etc.

[0878] A remote unit configured to be held in place by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through a hole in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion comprising a third a third cross-sectional area in a plane parallel to the first plane and configured to couple the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another, the third cross-sectional area being smaller than the first cross-sectional area and the second cross-sectional area, and configured to prevent the first portion and the second portion from moving through an opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; the coupling portion and the second portion are configured to form a coupling interface between the coupling portion and the second portion, wherein the second portion extends along a first direction parallel to the second plane, the second portion having a longitudinal cross-sectional area along the first direction, the second longitudinal cross-sectional area being smaller than the first longitudinal cross-sectional area, and the first longitudinal cross-sectional area being located closer to the coupling interface with respect to the first direction; In some embodiments, the second portion has a first end and a second end opposite the first end along the first direction, the second portion has a length between the first end and the second end, the second portion has an intermediate region and a distal region, the intermediate region is defined by a connection interface between the connecting portion and the second portion, and the distal region extends from the connection interface between the connecting portion and the second portion to the second end.

[0879] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the second end.

[0880] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the second end.

[0881] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the second end.

[0882] In some embodiments, the distal region of the second portion is conical.

[0883] In some embodiments, the second portion has rotational symmetry along the first direction.

[0884] In some embodiments, the second surface of the second portion is substantially perpendicular to the central extension of the connecting portion.

[0885] In some embodiments, the second surface of the second portion is substantially parallel to the second plane.

[0886] In some embodiments, the second surface of the second portion is substantially flat and configured to form a contact area against the second tissue surface, and the second portion further comprises a lower surface facing away from the first portion configured to taper toward the second end.

[0887] In some embodiments, the second portion has a proximal region that extends from the first end to a connection interface between the connecting portion and the second portion.

[0888] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the first end.

[0889] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the first end.

[0890] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the first end.

[0891] In some embodiments, the proximal region of the second portion is conical.

[0892] In some embodiments, the first end and the second end each comprise an elliptical point.

[0893] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0894] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0895] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0896] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0897] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0898] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0899] In some embodiments, the connection interface between the connecting portion and the second portion is eccentric relative to the second portion in a first direction but not in a second direction perpendicular to the first direction.

[0900] In some embodiments, the connection interface between the connecting portion and the second portion is eccentric relative to the second portion in a first direction and in a second direction perpendicular to the first direction.

[0901] In some embodiments, the second direction is parallel to a second plane.

[0902] In some embodiments, the proximal and distal regions comprise a second surface configured to engage a second surface of a second side of the tissue portion.

[0903] In some embodiments, the second portion tapers from the first end to the second end.

[0904] In some embodiments, the second portion tapers from an intermediate region of the second portion to each of the first and second ends.

[0905] In some embodiments, the first portion has a maximum dimension in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0906] In some embodiments, the first portion has a diameter in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0907] In some embodiments, the connecting portion has a maximum dimension in the third plane in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, for example in the range of 5 to 10 mm.

[0908] In some embodiments, the second portion has a maximum dimension in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, for example in the range of 35 to 60 mm.

[0909] In some embodiments, the first portion has one or more of a spherical shape, an ellipsoidal shape, a polyhedral shape, an elongated shape, and a flattened disk shape.

[0910] In some embodiments, the connecting portion has one of an oval cross-section, an elongated cross-section, and a circular cross-section in a plane parallel to the third plane.

[0911] In some embodiments, the distal region is configured to face downward in a standing patient.

[0912] In some embodiments, the first portion has a first height and the second portion has a second height, both heights being in a direction perpendicular to the first and second planes, and the first height being less than the second height.

[0913] In some embodiments, the first height is less than 2 / 3 of the second height, such as less than 1 / 2 of the second height, such as less than 1 / 3 of the second height.

[0914] In some embodiments, the second end of the second portion comprises a connection for connecting to an implant located caudally from the location of the remote unit within the patient.

[0915] In some embodiments, the first end of the second portion comprises a connection for connecting to an implant located cranially from the location of the remote unit within the patient.

[0916] In some embodiments, the connecting portion further comprises a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0917] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0918] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0919] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0920] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0921] In some embodiments, the second portion comprises a second wireless energy receiver.

[0922] In some embodiments, the first portion comprises a first energy storage unit.

[0923] In some embodiments, the second portion comprises a second energy storage unit.

[0924] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0925] In some embodiments, the solid state battery is a thionyl chloride battery.

[0926] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0927] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0928] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0929] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0930] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0931] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0932] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0933] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0934] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0935] In some embodiments, the remote unit further comprises a housing configured to enclose at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0936] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0937] In some embodiments, the remote unit further comprises a housing configured to enclose at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0938] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0939] In some embodiments, the remote unit further comprises at least one sensor for providing input to at least one of the first and second controllers.

[0940] In some embodiments, the sensor is a sensor configured to sense a physical parameter of the remote unit.

[0941] In some embodiments, the sensor is a sensor configured to sense at least one of a temperature of the remote unit or the body-engagement portion, a parameter related to power consumption of the remote unit or the body-engagement portion, a parameter related to the status of at least one of the first and second energy storage units, a parameter related to wireless transfer of energy from an energy source external to the patient's body, and fluid pressure.

[0942] In some embodiments, the sensor is a sensor configured to sense a physiological parameter of the patient.

[0943] In some embodiments, the sensor is a sensor configured to sense at least one of a parameter related to the patient's swallowing, local temperature, systemic temperature, blood saturation, blood oxygenation, blood pressure, a parameter related to an ischemic marker, and pH.

[0944] In some embodiments, the sensor configured to sense a parameter associated with the patient's swallowing comprises at least one of a motility sensor, an acoustic sensor, an optical sensor, and a strain sensor.

[0945] In some embodiments, the sensor configured to sense pH is configured to sense acidity in the stomach.

[0946] In some embodiments, the controller is configured to transmit information based on the sensor input to a device external to the patient's body.

[0947] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0948] In some embodiments, the second portion comprises at least one electric motor.

[0949] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion produced by the electric motor.

[0950] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0951] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0952] In some embodiments, the transmission comprises a gear system.

[0953] In some embodiments, the second portion comprises a magnetic coupling for transmitting mechanical work from the electric motor through one of a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing surrounding at least the second portion.

[0954] In some embodiments, the second part comprises at least one hydraulic pump.

[0955] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0956] In some embodiments, the remote unit further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0957] In some embodiments, at least one of the first and second portions comprises a sensation generator adapted to generate a sensation detectable by the patient's senses.

[0958] In some embodiments, the second portion includes a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0959] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit force from the second portion to the implant engaging portion.

[0960] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted body engaging portion.

[0961] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0962] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0963] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0964] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of the patient.

[0965] In some embodiments, the walls of the first chamber are elastic to allow for expansion of the first chamber.

[0966] In some embodiments, the second portion comprises a first hydraulic system in fluid communication with a first hydraulically actuable implant element configured to exert a force on the patient's body part and a second hydraulic system in fluid communication with a second hydraulically actuable implant element configured to exert a force on the patient's body part, wherein the first and second hydraulically actuable implant elements are adjustable independently of one another.

[0967] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0968] In some embodiments, each of the first and second hydraulic systems includes a reservoir for holding hydraulic fluid.

[0969] In some embodiments, the remote unit further comprises a first pressure sensor configured to sense pressure in the first hydraulic system and a second pressure sensor configured to sense pressure in the second hydraulic system.

[0970] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0971] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0972] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0973] In accordance with one embodiment of the present concept, there is provided an implantable device for exerting a force on a body part of a patient, the implantable device comprising a remote unit and an implantable element configured to exert a force on the body part of the patient.

[0974] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable hydraulic constriction device.

[0975] In some embodiments, the implantable hydraulic constriction device is configured to constrict a hollow organ of a patient.

[0976] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the patient's intestine.

[0977] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the colon or rectum of a patient.

[0978] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the intestine in the region of the patient's stoma.

[0979] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting a blood vessel in a patient.

[0980] In some embodiments, an implantable hydraulic constriction device for constricting a patient's blood vessels is configured to constrict venous blood flow leading from the erectile tissue to facilitate anchoring of the erectile tissue.

[0981] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting a blood vessel in a patient.

[0982] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively emptying the patient's bladder.

[0983] In some embodiments, the implantable element for actively emptying a patient's bladder is configured to empty the patient's bladder by compressing the bladder from the outside thereof.

[0984] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively stretching the patient's stomach wall to induce a feeling of satiety.

[0985] An implantable stricture device for constricting a patient's urethra is also provided. The implantable stricture device includes a surrounding structure having a periphery that surrounds at least a portion of the urethra when implanted; an operable hydraulic constriction element attached to the surrounding structure and configured to expand to constrict the urethra to restrict the flow of urine therethrough; and a fluid conduit attached to the surrounding structure and fluidly connected to the operable hydraulic constriction element. The surrounding structure, the operable hydraulic constriction element, and the fluid...

Claims

1. 1. A support element (24a) for an implantable stricture device for stricturing a patient's urethra, comprising: the support element (24a) is configured to form at least a part of a surrounding structure (20) configured to surround and support at least one operable hydraulic constriction element (101) configured to constrict the urethra (U) to restrict the flow of urine therethrough; the support element (24a) comprises at least one fluid conduit (109a) at least partially integrated within the support element (24a); an axis defining an angle of entry of the at least one fluid conduit (109a) into the support element (24a) is offset from an axis defining an angle of exit of the at least one fluid conduit (109a) out of the support element (24a); Supporting element (24a).

2. At least one fluid conduit (109a) is integrally integrated into the support element (24a); A support element (24a) according to claim 1.

3. The support element (24a) has at least one curved portion (C) adapted to the curvature of the urethra (U); A support element (24a) according to claim 1.

4. The curvature (C) is in the range of 3 mm to 50 mm, or the radius (R) is in the range of 5 mm to 30 mm. A support element (24a) according to claim 3.

5. The support element (24a) a first curvature (C) having a first radius (R1); a second curvature (C) having a second radius (R2), wherein the first radius (R1) is smaller than the second radius (R2); A support element (24a) according to claim 3.

6. a first operable hydraulic constriction element (101a) having a larger volume than a second operable hydraulic constriction element (101b); A support element (24a) according to claim 1.

7. a first operable hydraulic constriction element (101a) having a volume at least 1.5 times greater than a volume of a second operable hydraulic constriction element (101b); A support element (24a) according to claim 6.

8. The main part of the support element (24a) is in the range of 0.2 GPa to 1000 GPa. or made from a material having an elastic modulus (E) in the range of 1 GPa to 400 GPa; A support element (24a) according to any one of claims 1 to 7.

9. the support element (24a) comprises a connecting portion (24a') for connecting the support element (24a) to another support element (24b) for at least partially forming the surrounding structure (20); A support element (24a) according to any one of claims 1 to 7.

10. the connecting portion (24a') comprises part of a hinge (26) for hingedly connecting the support element (24a) to another support element (24b) for at least partially forming the surrounding structure (20); A support element (24a) according to claim 9.

11. the support element (24a) comprises a second fluid conduit (109b) at least partially integrated into the support element (24a), the first at least partially integrated fluid conduit (109a) configured to conduct fluid to the first operable hydraulic constriction element (101a), and the second at least partially integrated fluid conduit (109b) configured to conduct fluid to the second operable hydraulic constriction element (101b); A support element (24a) according to any one of claims 1 to 7.

12. the support element (24a) comprises an outer surface (21) configured to be oriented away from the urethra when implanted, the outer surface (21) comprising at least one inlet for at least one fluid conduit (109a), the at least one inlet configured to be in fluid communication with a hydraulic pump (104) for pumping fluid to a hydraulic constriction element (101a) operable to constrict the urethra (U); A support element (24a) according to any one of claims 1 to 7.

13. a support element (24a) having a length (11) in the axial direction (AD) of the urethra (U) when implanted, and at least one operable hydraulic constriction element (101) having a length (12) in the axial direction (AD) of the urethra (U) when implanted, the length (12) of the at least one operable hydraulic constriction element (101) being longer than the length (11) of the support element (24); A support element (24a) according to any one of claims 1 to 7.

14. the support element (24a) further comprises an electrode arrangement disposed between the support element (24a) and the urethra (U) and configured to engage and electrically stimulate musculature of the urethra (U) to exercise the musculature and improve the long-term implantation condition of the implantable constriction device (10); A support element (24a) according to any one of claims 1 to 7.

15. A surrounding structure (20) for an implantable stricture device (10) for stricturing a patient's urethra (U), the surrounding structure (20) being configured to surround the urethra (U) when implanted, and comprising at least one support element (24a) according to claim 1. Surrounding structures (20).

16. the surrounding structure (20) comprises a second support element (24b), the first and second support elements (24a, 24b) being configured to be connected and together forming at least a part of the surrounding structure (20); A surrounding structure (20) according to claim 15.

17. The first and second support elements (24a, 24b) are configured to form a surrounding structure (20) and thereby surround the urethra (U); A surrounding structure (20) according to claim 16.

18. The first and second support elements (24a, 24b) are hingedly connected to one another to form a surrounding structure (20), the peripheral edge (P) of the surrounding structure (20) being openable so that the surrounding structure (20) can be placed around the urethra (U). A surrounding structure (20) according to claim 17.

19. the second support element (24b) comprises at least one cushion element (30) configured to contact the urethra (U), the cushion element (30) being more resilient than the support element (24b); A surrounding structure (20) according to any one of claims 16 to 18.

20. the surrounding structure (20) further comprises an electrode arrangement configured to be positioned between the surrounding structure (20) and the urethra (U) and configured to engage and electrically stimulate muscle tissue of the urethra (U) to cause muscle tissue movement and improve long-term implant conditions of the implantable stricture device (10); A surrounding structure (20) according to any one of claims 15 to 18.

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